Identity
- Trade Name
- TOMOFIX FDA UDI
- Generic Name
- Orthopaedic fixation plate, non-bioabsorbable FDA UDI
- Device Name
- TI TOMOFIX MEDIAL DISTAL FEMUR PL-4 HOLES/LT-STERILE FDA UDI
- Model / Reference
- 440.895S FDA UDI
- Description
- TI TOMOFIX MEDIAL DISTAL FEMUR PL-4 HOLES/LT-STERILE FDA UDI
Identifiers
- Catalog Number
- 440895S FDA UDI
- Primary DI / UDI-DI
- 10886982220820 FDA UDI
- 510(k) Number
- K081353 FDA UDI
- FDA Product Code
- HRS FDA UDI
- GMDN Term
- Orthopaedic fixation plate, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Tomofix by Synthes (u.s.a.) Lp — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 (u.s.a.) Lp
Sources (1)
- FDA UDI b6e255ee-0456-43b4-a5d4-8d68080e7eaf 37 fields · synced Jun 1, 2026