Identity
- Trade Name
- AGC REVISION KNEE FDA UDI
- Generic Name
- Knee arthroplasty wedge FDA UDI
- Model / Reference
- 154552 FDA UDI
Identifiers
- Catalog Number
- 154552 FDA UDI
- Primary DI / UDI-DI
- 05019279387830 FDA UDI
- 510(k) Number
- K984054 FDA UDI
- FDA Product Code
- JWH FDA UDI
- GMDN Term
- Knee arthroplasty wedge FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3560 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: Knee arthroplasty wedge
Agc Revision Knee by Biomet Uk Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Knee arthroplasty wedge.
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- LEGION — Smith & Nephew, Inc. · Class II
- ADVANTIM® — MicroPort Orthopedics Inc. · Class II
- LinkSymphoKnee — WALDEMAR LINK GmbH & Co. KG · Class II
- Unity Total Knee System — CORIN LTD · Class II
Cleared under the same submission
K984054 also covers:
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 Uk Ltd
Sources (1)
- FDA UDI d0496a69-7d65-487e-97d9-33d95e72ef65 36 fields · synced May 30, 2026