Identity
- Trade Name
- Prosthesis Head A FDA UDI
- Generic Name
- Ceramic femoral head prosthesis FDA UDI
- Device Name
- Modular Prosthesis Head,Ceramic - Biolox forte FDA UDI
- Model / Reference
- 128-761 FDA UDI
- Description
- Modular Prosthesis Head,Ceramic - Biolox forte FDA UDI
Identifiers
- Catalog Number
- 128-761 FDA UDI
- Primary DI / UDI-DI
- 04026575028245 FDA UDI
- 510(k) Number
- K920756 FDA UDI
- FDA Product Code
- LZO FDA UDI
- GMDN Term
- Ceramic femoral head prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3353 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Ceramic femoral head prosthesis
Prosthesis Head A by WALDEMAR LINK GmbH & Co. KG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ceramic femoral head prosthesis.
- Ceramic ball head — Beijing LiDaKang Technology Co., Ltd. · Class III
- ELEC(R)plus — HiPer Medical AG · Class III
- BIOLOX® delta Modular Ceramic Head — Biomet Uk Ltd · Class II
- InSitu Hip System — Nextstep Arthropedix · Class II
- InSitu Hip System — Nextstep Arthropedix · Class II
- SYNERGY — Smith & Nephew, Inc. · Class II
- DJO SURGICAL — ENCORE MEDICAL, L.P. · Class II
- BENCOX Hip System — Corentec Co., Ltd · Class II
Cleared under the same submission
K920756 also covers:
- Prosthesis Head A — WALDEMAR LINK GmbH & Co. KG
- Prosthesis Head A — WALDEMAR LINK GmbH & Co. KG
- Prosthesis Head A — WALDEMAR LINK GmbH & Co. KG
- Prosthesis Head A — WALDEMAR LINK GmbH & Co. KG
- Prosthesis Head A — WALDEMAR LINK GmbH & Co. KG
- Prosthesis Head A — WALDEMAR LINK GmbH & Co. KG
- Prosthesis Head A — WALDEMAR LINK GmbH & Co. KG
- Prosthesis Head A — WALDEMAR LINK GmbH & Co. KG
- Prosthesis Head A — WALDEMAR LINK GmbH & Co. KG
- Prosthesis Head A — WALDEMAR LINK GmbH & Co. KG
- Prosthesis Head A — WALDEMAR LINK GmbH & Co. KG
- Prosthesis Head A — WALDEMAR LINK GmbH & Co. KG
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
- WALDEMAR LINK GmbH & Co. KG
Sources (1)
- FDA UDI 6f80db28-8391-4b7f-a558-34ff0e050e61 35 fields · synced May 30, 2026