Identity
- Trade Name
- PlusDrive FDA UDI
- Generic Name
- Craniofacial bone screw, non-bioabsorbable FDA UDI
- Device Name
- 2.0MM TI CRTX SCREW SLF-TPNG W/PLUSDRIVE(TM) RECESS 8MM FDA UDI
- Model / Reference
- 401.044 FDA UDI
- Description
- 2.0MM TI CRTX SCREW SLF-TPNG W/PLUSDRIVE(TM) RECESS 8MM FDA UDI
Identifiers
- Catalog Number
- 401044 FDA UDI
- Primary DI / UDI-DI
- 20887587045754 FDA UDI
- FDA Product Code
- JEY FDA UDIDZL FDA UDIMQN FDA UDIPBJ FDA UDI
- GMDN Term
- Craniofacial bone screw, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.4760 FDA UDI872.4880 FDA UDI882.5330 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Craniofacial bone screw, non-bioabsorbable
PlusDrive by Synthes — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Craniofacial bone screw, non-bioabsorbable.
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- OsteoMed — Osteomed Corp. · Class II
- LEVEL ONE NEURO, STERILE — KLS-Martin L.P. · Class II
- Leforte System Bone Screw / GBR System Bone Screw — Jeil Medical Corporation · Class II
- LEVEL ONE CMF — KLS-Martin L.P. · Class II
Cleared under the same submission
K102656 also covers:
K162594 also covers:
K170818 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Synthes
Sources (1)
- FDA UDI 52fe46c1-6580-41c0-ac48-4f316a8bea95 36 fields · synced May 30, 2026