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Trabecular Metal®
EUDAMEDFDA UDIClass I (EU MDR)
Ref 00-4501-050-03Ref 00-4501-051-01Ref 00-4501-057-00
by Zimmer, Inc.
Identity
- Trade Name
- Trabecular Metal® EUDAMEDFDA UDI
- Generic Name
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
- Device Name
- Zimmer Frame EUDAMEDZimmer Foot Plate EUDAMEDZimmer Guard Stop EUDAMED
- Model / Reference
- 00-4501-050-03 EUDAMEDFDA UDI00-4501-057-00 EUDAMEDFDA UDI00-4501-051-01 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 00-4501-057-00 FDA UDI00-4501-050-03 FDA UDI00-4501-051-01 FDA UDI
- Primary DI / UDI-DI
- 00889024270749 EUDAMEDFDA UDI00889024270954 EUDAMEDFDA UDI00889024270787 EUDAMEDFDA UDI
- Basic UDI-DI
- 889024AE7YE EUDAMED889024AE8YG EUDAMED889024AECZ4 EUDAMED
- 510(k) Number
- K120906 FDA UDI
- FDA Product Code
- HSN FDA UDI
- EMDN Code
- Z12021199 ORTHOPAEDIC ENDOSCOPY INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3110 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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: Rigid endoscope obturator
Trabecular Metal® by Zimmer, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 889024AE7YE | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Zimmer, Inc.
- EUDAMED SRN
- US-MF-000001146
- Authorised Representative
- Biomet Global Supply Chain Center B.V. NL-AR-000000422
Sources (6)
- EUDAMED d0b3a4ec-28b6-4f95-99ff-b5edc5fe2c3a 61 fields · synced Aug 2, 2026
- FDA UDI 2436d183-5e5a-472f-b7d9-b10867e3f4b6 35 fields · synced May 30, 2026
- FDA UDI 53f6a8db-4617-4437-92f9-147b100816fa 35 fields · synced May 30, 2026
- FDA UDI 724154e0-8de1-4914-a352-531af1bc0183 35 fields · synced May 30, 2026
- EUDAMED e45c018b-e053-4553-bd20-6ebaec9ed4b4 61 fields · synced Jul 28, 2026
- EUDAMED 451000ab-1449-4fd6-9c8c-9d076f56a8b5 61 fields · synced Aug 2, 2026