400834E

GUDID H980400834E0

TI LOW PROFILE NEURO SCREW SELF-DRILLING 4MM

SYNTHES (U.S.A.) LP

Craniofacial bone screw, non-bioabsorbable, sterile Craniofacial bone screw, non-bioabsorbable, sterile Craniofacial bone screw, non-bioabsorbable, sterile Craniofacial bone screw, non-bioabsorbable, sterile Craniofacial bone screw, non-bioabsorbable, sterile Craniofacial bone screw, non-bioabsorbable, sterile Craniofacial bone screw, non-bioabsorbable, sterile Craniofacial bone screw, non-bioabsorbable, sterile Craniofacial bone screw, non-bioabsorbable, sterile Craniofacial bone screw, non-bioabsorbable, sterile Craniofacial bone screw, non-bioabsorbable, sterile Craniofacial bone screw, non-bioabsorbable, sterile Craniofacial bone screw, non-bioabsorbable, sterile Craniofacial bone screw, non-bioabsorbable, sterile Craniofacial bone screw, non-bioabsorbable, sterile Craniofacial bone screw, non-bioabsorbable, sterile Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable

• Primary Device ID: H980400834E0
• NIH Device Record Key: e389d5c8-1671-4051-abd6-edc8c251275d
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 400.834E
• Catalog Number: 400834E
• Company DUNS: 832637081
• Company Name: SYNTHES (U.S.A.) LP
• Device Count: 1
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10887587045429 [Primary]
HIBCC	H980400834E0 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K022012

FDA Product Code

• JEY: PLATE, BONE

Sterilization

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

[H980400834E0]

Moist Heat or Steam Sterilization

[H980400834E0]

Moist Heat or Steam Sterilization

[H980400834E0]

Moist Heat or Steam Sterilization

[H980400834E0]

Moist Heat or Steam Sterilization

[H980400834E0]

Moist Heat or Steam Sterilization

[H980400834E0]

Moist Heat or Steam Sterilization

[H980400834E0]

Moist Heat or Steam Sterilization

[H980400834E0]

Moist Heat or Steam Sterilization

[H980400834E0]

Moist Heat or Steam Sterilization

[H980400834E0]

Moist Heat or Steam Sterilization

[H980400834E0]

Moist Heat or Steam Sterilization

[H980400834E0]

Moist Heat or Steam Sterilization

[H980400834E0]

Moist Heat or Steam Sterilization

[H980400834E0]

Moist Heat or Steam Sterilization

[H980400834E0]

Moist Heat or Steam Sterilization

[H980400834E0]

Moist Heat or Steam Sterilization

[H980400834E0]

Moist Heat or Steam Sterilization

[H980400834E0]

Moist Heat or Steam Sterilization

[H980400834E0]

Moist Heat or Steam Sterilization

[H980400834E0]

Moist Heat or Steam Sterilization

[H980400834E0]

Moist Heat or Steam Sterilization

[H980400834E0]

Moist Heat or Steam Sterilization

[H980400834E0]

Moist Heat or Steam Sterilization

[H980400834E0]

Moist Heat or Steam Sterilization

[H980400834E0]

Moist Heat or Steam Sterilization

[H980400834E0]

Moist Heat or Steam Sterilization

[H980400834E0]

Moist Heat or Steam Sterilization

[H980400834E0]

Moist Heat or Steam Sterilization

[H980400834E0]

Moist Heat or Steam Sterilization

[H980400834E0]

Moist Heat or Steam Sterilization

[H980400834E0]

Moist Heat or Steam Sterilization

[H980400834E0]

Moist Heat or Steam Sterilization

[H980400834E0]

Moist Heat or Steam Sterilization

[H980400834E0]

Moist Heat or Steam Sterilization

[H980400834E0]

Moist Heat or Steam Sterilization

[H980400834E0]

Moist Heat or Steam Sterilization

[H980400834E0]

Moist Heat or Steam Sterilization

[H980400834E0]

Moist Heat or Steam Sterilization

[H980400834E0]

Moist Heat or Steam Sterilization

[H980400834E0]

Moist Heat or Steam Sterilization

[H980400834E0]

Moist Heat or Steam Sterilization

[H980400834E0]

Moist Heat or Steam Sterilization

[H980400834E0]

Moist Heat or Steam Sterilization

[H980400834E0]

Moist Heat or Steam Sterilization

[H980400834E0]

Moist Heat or Steam Sterilization

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

Devices Manufactured by SYNTHES (U.S.A.) LP

• H981023060100 - NA: 2024-07-12 6.0MM PELVIC ROD-LEFT
• H981023060120 - NA: 2024-07-12 6.0MM PELVIC ROD-RIGHT
• H981042006140 - Axon: 2024-07-12 3.5MM TI CANCELLOUS AXON(TM) SCREW 28MM THREAD LENGTH
• H981042006150 - Axon: 2024-07-12 3.5MM TI CANCELLOUS AXON(TM) SCREW 30MM THREAD LENGTH
• H981042006160 - Axon: 2024-07-12 3.5MM TI CANCELLOUS AXON(TM) SCREW 32MM THREAD LENGTH
• H981042006170 - Axon: 2024-07-12 3.5MM TI CANCELLOUS AXON(TM) SCREW 34MM THREAD LENGTH
• H981042006180 - Axon: 2024-07-12 3.5MM TI CANCELLOUS AXON(TM) SCREW 36MM THREAD LENGTH
• H981042006190 - Axon: 2024-07-12 3.5MM TI CANCELLOUS AXON(TM) SCREW 38MM THREAD LENGTH