Identity
- Trade Name
- CENTRALOC TIBIAL FIXATION FDA UDI
- Generic Name
- Orthopaedic fixation plate, bioabsorbable FDA UDI
- Model / Reference
- 905683 FDA UDI
Identifiers
- Catalog Number
- 905683 FDA UDI
- Primary DI / UDI-DI
- 00880304421141 FDA UDI
- 510(k) Number
- K033233 FDA UDI
- FDA Product Code
- MAI FDA UDIHWC FDA UDI
- GMDN Term
- Orthopaedic fixation plate, bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 FDA UDI888.3040 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
Category: Orthopaedic fixation plate, bioabsorbable
Centraloc Tibial Fixation by Biomet Sports Medicine — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic fixation plate, bioabsorbable.
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- 1.5 mm Inion CPS® — Inion , Ltd. · Class II
- 2.0 mm Inion CPS® — Inion , Ltd. · Class II
- 2.0 mm Inion CPS® — Inion , Ltd. · Class II
- 2.0 mm Inion CPS® — Inion , Ltd. · Class II
- 1.5 mm Inion CPS® — Inion , Ltd. · Class II
Cleared under the same submission
K033233 also covers:
- CENTRALOC TIBIAL FIXATION — Biomet Sports Medicine
- CENTRALOC TIBIAL FIXATION — Biomet Sports Medicine
- CENTRALOC TIBIAL FIXATION — Biomet Sports Medicine
- CENTRALOC TIBIAL FIXATION — Biomet Sports Medicine
- CENTRALOC TIBIAL FIXATION — Biomet Sports Medicine
- CENTRALOC TIBIAL FIXATION — Biomet Sports Medicine
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biomet Sports Medicine
Sources (1)
- FDA UDI 7c9d9b65-5671-4822-9c39-7121bc5c2505 36 fields · synced May 30, 2026