Identity
- Trade Name
- TRABECULAR METAL™ FDA UDI
- Generic Name
- Hip internal fixation system FDA UDI
- Model / Reference
- 00-1197-080-10 FDA UDI
Identifiers
- Catalog Number
- 00-1197-080-10 FDA UDI
- Primary DI / UDI-DI
- 00889024305991 FDA UDI
- 510(k) Number
- K050101 FDA UDI
- FDA Product Code
- HRS FDA UDI
- GMDN Term
- Hip internal fixation system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
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
Dimensions & Sizes
- Size
- Length — 80 Millimeter FDA UDI
Category: Hip internal fixation system
Trabecular Metal™ by Zimmer Trabecular Metal Technology, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Hip internal fixation system.
- TSP HIP FX PLATING SYSTEM7.5MM TELESCOPING LAG SCREW — Biomet Orthopedics, Inc. · Class II
- Zimmer® Natural Nail® System — Zimmer, Inc. · Class II
- TSP HIP FX PLATING SYSTEMLIMITED COLLAPSE SLEEVE — Biomet Orthopedics, Inc. · Class II
- TSP HIP FX PLATING SYSTEMNECK FRACTURE PLATE — Biomet Orthopedics, Inc. · Class II
- Zimmer® Natural Nail™ System — Zimmer, Inc. · Class II
- TSP HIP FX PLATING SYSTEMLIMITED COLLAPSE SLEEVE — Biomet Orthopedics, Inc. · Class II
- Zimmer® Natural Nail™ System — Zimmer, Inc. · Class II
- TSP HIP FX PLATING SYSTEM7.5MM TELESCOPING LAG SCREW — Biomet Orthopedics, Inc. · Class II
Cleared under the same submission
K050101 also covers:
- TRABECULAR METAL™ — Zimmer Trabecular Metal Technology, Inc.
- TRABECULAR METAL™ — Zimmer Trabecular Metal Technology, Inc.
- TRABECULAR METAL™ — Zimmer Trabecular Metal Technology, Inc.
- TRABECULAR METAL™ — Zimmer Trabecular Metal Technology, Inc.
- TRABECULAR METAL™ — Zimmer Trabecular Metal Technology, Inc.
- TRABECULAR METAL™ — Zimmer Trabecular Metal Technology, Inc.
- TRABECULAR METAL™ — Zimmer Trabecular Metal Technology, Inc.
- TRABECULAR METAL™ — Zimmer Trabecular Metal Technology, Inc.
- TRABECULAR METAL™ — Zimmer Trabecular Metal Technology, Inc.
- TRABECULAR METAL™ — Zimmer Trabecular Metal Technology, Inc.
- TRABECULAR METAL™ — Zimmer Trabecular Metal Technology, Inc.
- TRABECULAR METAL™ — Zimmer Trabecular Metal Technology, Inc.
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
- Zimmer Trabecular Metal Technology, Inc.
Sources (1)
- FDA UDI eb04d4c7-46a8-479c-bb4b-1c85df415170 36 fields · synced May 29, 2026