Identity
- Trade Name
- Trabecular Metal™ FDA UDI
- Generic Name
- Vertebral body prosthesis FDA UDI
- Model / Reference
- 06-165-02101 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00889024314511 FDA UDI
- 510(k) Number
- K051196 FDA UDI
- FDA Product Code
- MQP FDA UDI
- GMDN Term
- Vertebral body prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3060 FDA UDI
- Commercial Distribution
- 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
Dimensions & Sizes
- Size
- Height — 10 Millimeter FDA UDI
Category: Vertebral body prosthesis
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 Vertebral body prosthesis.
- CASCADIA™ Interbody System — K2M, INC. · Class II
- CHESAPEAKE® Stabilization System — K2M, INC. · Class II
- CASCADIA™ Interbody System — K2M, INC. · Class II
- FORTIFY — GLOBUS MEDICAL, INC. · Class II
- VERTE-STACK® Spinal System — MEDTRONIC SOFAMOR DANEK, INC. · Class II
- CASCADIA™ Interbody System — K2M, INC. · Class II
- CAPRI™ Corpectomy Cage System — K2M, INC. · Class II
- Cascadia™ Interbody System — K2M, INC. · Class II
Cleared under the same submission
K051196 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 f2be68a0-9735-4378-9ea0-bd7a0cbbcbf9 35 fields · synced May 30, 2026