OrthoMesh 80360502S

GUDID H67980360502S0

1.5MM RESORBABLE CORTEX SCREW 5MM FOR ORTHOMESH-STERILE

SYNTHES (U.S.A.) LP

Orthopaedic bone screw, bioabsorbable Orthopaedic bone screw, bioabsorbable Orthopaedic bone screw, bioabsorbable Orthopaedic bone screw, bioabsorbable Orthopaedic bone screw, bioabsorbable Orthopaedic bone screw, bioabsorbable Orthopaedic bone screw, bioabsorbable Orthopaedic bone screw, bioabsorbable Orthopaedic bone screw, bioabsorbable Orthopaedic bone screw, bioabsorbable Orthopaedic bone screw, bioabsorbable Orthopaedic bone screw, bioabsorbable Orthopaedic bone screw, bioabsorbable Orthopaedic bone screw, bioabsorbable Orthopaedic bone screw, bioabsorbable Orthopaedic bone screw, bioabsorbable Orthopaedic bone screw, bioabsorbable Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw

• Primary Device ID: H67980360502S0
• NIH Device Record Key: 312cc5db-569f-4aeb-9441-634783eee853
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OrthoMesh
• Version Model Number: 803.605.02S
• Catalog Number: 80360502S
• Company DUNS: 832637081
• Company Name: SYNTHES (U.S.A.) LP
• Device Count: 2
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx

Operating and Storage Conditions

• Handling Environment Temperature: Between 0 and 43 Degrees Celsius
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 110 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 43 Degrees Celsius
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 110 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 43 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *.
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 43 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *.
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 43 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *.
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 43 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *.
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 43 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *.
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 43 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *.
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 43 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *.
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 43 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *.
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 43 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *.
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 43 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *.
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 43 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *.
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 43 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *.
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 43 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *.
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 43 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *.
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 43 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *.
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 43 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *.
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 43 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *.
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 43 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *.
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 43 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *.
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 43 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *.
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 43 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *.
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 43 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *.
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 43 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *.
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 43 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *.
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 43 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *.
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 43 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *.
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 43 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *.
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 43 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *.
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 43 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *.
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 43 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *.
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 43 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *.
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 43 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *.
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 43 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *.
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 43 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *.
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 43 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *.
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 43 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *.
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 43 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *.
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 43 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *.
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 43 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *.
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 43 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *.
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 43 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *.
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 43 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *.
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 43 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *.
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	20886982255935 [Primary]
GS1	80886982255937 [Unit of Use]
HIBCC	H67980360502S0 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K073115

FDA Product Code

• HRS: PLATE, FIXATION, BONE

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-14

On-Brand Devices [OrthoMesh]

• H67980400602S0: 2.0MM RESORBABLE CORTEX SCREW 6MM FOR ORTHOMESH-STERILE
• H67980360502S0: 1.5MM RESORBABLE CORTEX SCREW 5MM FOR ORTHOMESH-STERILE