40136299

GUDID H981401362990

2.0MM TI CORTEX SCREW SLF-TPNG WITH STARDRIVE(TM) RECESS 12M

Synthes GmbH

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: H981401362990
• NIH Device Record Key: 8826697c-4997-4613-9d69-cba15d4edd47
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 401.362.99
• Catalog Number: 40136299
• Company DUNS: 486711679
• Company Name: Synthes GmbH
• 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
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• 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	10705034778853 [Primary]
HIBCC	H981401362990 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K032534

FDA Product Code

• NQW: ORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METAL

Sterilization

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

[H981401362990]

Moist Heat or Steam Sterilization

[H981401362990]

Moist Heat or Steam Sterilization

[H981401362990]

Moist Heat or Steam Sterilization

[H981401362990]

Moist Heat or Steam Sterilization

[H981401362990]

Moist Heat or Steam Sterilization

[H981401362990]

Moist Heat or Steam Sterilization

[H981401362990]

Moist Heat or Steam Sterilization

[H981401362990]

Moist Heat or Steam Sterilization

[H981401362990]

Moist Heat or Steam Sterilization

[H981401362990]

Moist Heat or Steam Sterilization

[H981401362990]

Moist Heat or Steam Sterilization

[H981401362990]

Moist Heat or Steam Sterilization

[H981401362990]

Moist Heat or Steam Sterilization

[H981401362990]

Moist Heat or Steam Sterilization

[H981401362990]

Moist Heat or Steam Sterilization

[H981401362990]

Moist Heat or Steam Sterilization

[H981401362990]

Moist Heat or Steam Sterilization

[H981401362990]

Moist Heat or Steam Sterilization

[H981401362990]

Moist Heat or Steam Sterilization

[H981401362990]

Moist Heat or Steam Sterilization

[H981401362990]

Moist Heat or Steam Sterilization

[H981401362990]

Moist Heat or Steam Sterilization

[H981401362990]

Moist Heat or Steam Sterilization

[H981401362990]

Moist Heat or Steam Sterilization

[H981401362990]

Moist Heat or Steam Sterilization

[H981401362990]

Moist Heat or Steam Sterilization

[H981401362990]

Moist Heat or Steam Sterilization

[H981401362990]

Moist Heat or Steam Sterilization

[H981401362990]

Moist Heat or Steam Sterilization

[H981401362990]

Moist Heat or Steam Sterilization

[H981401362990]

Moist Heat or Steam Sterilization

[H981401362990]

Moist Heat or Steam Sterilization

[H981401362990]

Moist Heat or Steam Sterilization

[H981401362990]

Moist Heat or Steam Sterilization

[H981401362990]

Moist Heat or Steam Sterilization

[H981401362990]

Moist Heat or Steam Sterilization

[H981401362990]

Moist Heat or Steam Sterilization

[H981401362990]

Moist Heat or Steam Sterilization

[H981401362990]

Moist Heat or Steam Sterilization

[H981401362990]

Moist Heat or Steam Sterilization

[H981401362990]

Moist Heat or Steam Sterilization

[H981401362990]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-04-27
• Device Publish Date: 2015-09-14

Devices Manufactured by Synthes GmbH

• 10886982350435 - NA: 2026-02-19 HALF BENNETT SMALL/LEFT
• 10886982350442 - NA: 2026-02-19 HALF BENNETT SMALL/RIGHT
• 10886982350459 - NA: 2026-02-19 HALF BENNETT LARGE/LEFT
• 10886982350466 - NA: 2026-02-19 HALF BENNETT LARGE/RIGHT
• 10886982351579 - NA: 2026-02-19 SHOULDER HOOK 2.2 MM TIP / 235 MM LENGTH
• 10886982351661 - NA: 2026-02-19 T-HANDLE AO CONNECTOR
• 10886982351678 - NA: 2026-02-19 T-HANDLE LARGE AO CONNECTOR
• 10886982361288 - NA: 2026-02-19 5MM AWL, QC