08025057S

GUDID H67908025057S0

RESORBABLE SLEEVE FOR 6.0MM ANGULAR STABLE LCKNG SCR-STER

SYNTHES (U.S.A.) LP

Internal orthopaedic fixation system, plate/screw, bioabsorbable Internal orthopaedic fixation system, plate/screw, bioabsorbable Internal orthopaedic fixation system, plate/screw, bioabsorbable Internal orthopaedic fixation system, plate/screw, bioabsorbable Internal orthopaedic fixation system, plate/screw, bioabsorbable Internal orthopaedic fixation system, plate/screw, bioabsorbable Internal orthopaedic fixation system, plate/screw, bioabsorbable Internal orthopaedic fixation system, plate/screw, bioabsorbable Internal orthopaedic fixation system, plate/screw, bioabsorbable Internal orthopaedic fixation system, plate/screw, bioabsorbable Internal orthopaedic fixation system, plate/screw, bioabsorbable Internal orthopaedic fixation system, plate/screw, bioabsorbable Internal orthopaedic fixation system, plate/screw, bioabsorbable Internal orthopaedic fixation system, plate/screw, bioabsorbable Internal orthopaedic fixation system, plate/screw, bioabsorbable Internal orthopaedic fixation system, plate/screw, bioabsorbable Internal orthopaedic fixation system, plate/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

• Primary Device ID: H67908025057S0
• NIH Device Record Key: 7da0f84a-20fc-41e7-9edf-7d5f5315f6cb
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 08.025.057S
• Catalog Number: 08025057S
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	20886982131925 [Primary]
GS1	80886982131927 [Unit of Use]
HIBCC	H67908025057S0 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090241

FDA Product Code

• HSB: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Sterilization

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

[H67908025057S0]

Moist Heat or Steam Sterilization

[H67908025057S0]

Moist Heat or Steam Sterilization

[H67908025057S0]

Moist Heat or Steam Sterilization

[H67908025057S0]

Moist Heat or Steam Sterilization

[H67908025057S0]

Moist Heat or Steam Sterilization

[H67908025057S0]

Moist Heat or Steam Sterilization

[H67908025057S0]

Moist Heat or Steam Sterilization

[H67908025057S0]

Moist Heat or Steam Sterilization

[H67908025057S0]

Moist Heat or Steam Sterilization

[H67908025057S0]

Moist Heat or Steam Sterilization

[H67908025057S0]

Moist Heat or Steam Sterilization

[H67908025057S0]

Moist Heat or Steam Sterilization

[H67908025057S0]

Moist Heat or Steam Sterilization

[H67908025057S0]

Moist Heat or Steam Sterilization

[H67908025057S0]

Moist Heat or Steam Sterilization

[H67908025057S0]

Moist Heat or Steam Sterilization

[H67908025057S0]

Moist Heat or Steam Sterilization

[H67908025057S0]

Moist Heat or Steam Sterilization

[H67908025057S0]

Moist Heat or Steam Sterilization

[H67908025057S0]

Moist Heat or Steam Sterilization

[H67908025057S0]

Moist Heat or Steam Sterilization

[H67908025057S0]

Moist Heat or Steam Sterilization

[H67908025057S0]

Moist Heat or Steam Sterilization

[H67908025057S0]

Moist Heat or Steam Sterilization

[H67908025057S0]

Moist Heat or Steam Sterilization

[H67908025057S0]

Moist Heat or Steam Sterilization

[H67908025057S0]

Moist Heat or Steam Sterilization

[H67908025057S0]

Moist Heat or Steam Sterilization

[H67908025057S0]

Moist Heat or Steam Sterilization

[H67908025057S0]

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

• H679022101060 - NA: 2024-02-27 2.4MM VA LOCKING SCREW STARDRIVE 6MM
• H679022221140 - NA: 2024-02-27 5.0MM VA LOCKING SCREW SLF-TPNG W/T25 STARDRIVE/14MM
• H679022221160 - NA: 2024-02-27 5.0MM VA LOCKING SCREW SLF-TPNG W/T25 STARDRIVE/16MM
• H679022221180 - NA: 2024-02-27 5.0MM VA LOCKING SCREW SLF-TPNG W/T25 STARDRIVE/18MM
• H679022221200 - NA: 2024-02-27 5.0MM VA LOCKING SCREW SLF-TPNG W/T25 STARDRIVE/20MM
• H679022221220 - NA: 2024-02-27 5.0MM VA LOCKING SCREW SLF-TPNG W/T25 STARDRIVE/22MM
• H679022221240 - NA: 2024-02-27 5.0MM VA LOCKING SCREW SLF-TPNG W/T25 STARDRIVE/24MM
• H679022221260 - NA: 2024-02-27 5.0MM VA LOCKING SCREW SLF-TPNG W/T25 STARDRIVE/26MM