Prosthesis Head B
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Prosthesis Head B FDA UDI
- Generic Name
- Metallic femoral head prosthesis FDA UDI
- Device Name
- Prosthesis Heads B EUDAMEDModular Prosthesis Head,CoCrMo FDA UDI
- Model / Reference
- 128-836/02 EUDAMEDFDA UDIProsthesis head, uncemented, CoCrMo, 12/14 taper EUDAMED128-826/02 FDA UDI
- Description
- Modular Prosthesis Head,CoCrMo FDA UDI
Identifiers
- Catalog Number
- 128-826/02 FDA UDI128-836/02 FDA UDI
- Primary DI / UDI-DI
- 04026575404711 EUDAMEDFDA UDI04026575365104 FDA UDI
- Basic UDI-DI
- 4026575-1-HSP-031001-W6 EUDAMED
- 510(k) Number
- K953653 FDA UDI
- FDA Product Code
- JDG FDA UDI
- EMDN Code
- P090804050202 METAL FEMORAL HEADS, TOTAL HIP REPLACEMENT EUDAMED
- GMDN Term
- Metallic femoral head prosthesis FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3360 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
Yes
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
Yes
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
Yes
Manufacturing Date
No
Category: Metallic femoral head prosthesis
Prosthesis Head B by WALDEMAR LINK GmbH & Co. KG — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Metallic femoral head prosthesis.
- Normmed CoCr Femoral Head 28 +12 — NORMMED MEDİKAL SAN. VE TİC. A.Ş. · Class III
- Consensus Hip System — SHALBY ADVANCED TECHNOLOGIES, INC. · Class II
- Orthinox — Howmedica Osteonics Corp. · Class II
- Orthinox — Howmedica Osteonics Corp. · Class II
- A110212031 — EUROS SAS · Class III
- Consensus Hip System — SHALBY ADVANCED TECHNOLOGIES, INC. · Class II
- BIOMET HIP SYSTEM — Biomet Orthopedics, Inc. · Class II
- Femoral Head — SIGNATURE ORTHOPAEDICS PTY LTD · Class II
Cleared under the same submission
K953653 also covers:
- Prosthesis Head A — WALDEMAR LINK GmbH & Co. KG
- Prosthesis Head B — WALDEMAR LINK GmbH & Co. KG
- Prosthesis Head B — WALDEMAR LINK GmbH & Co. KG
- Prosthesis Head B — WALDEMAR LINK GmbH & Co. KG
- Prosthesis Head B — WALDEMAR LINK GmbH & Co. KG
- Prosthesis Head B — WALDEMAR LINK GmbH & Co. KG
- Prosthesis Head B — WALDEMAR LINK GmbH & Co. KG
- Prosthesis Head B — WALDEMAR LINK GmbH & Co. KG
- Prosthesis Head B — WALDEMAR LINK GmbH & Co. KG
- Prosthesis Head B — WALDEMAR LINK GmbH & Co. KG
- Prosthesis Head B — WALDEMAR LINK GmbH & Co. KG
- Prosthesis Head B — WALDEMAR LINK GmbH & Co. KG
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| 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 (3)
- FDA UDI 57827e57-c0d7-4d25-be31-f3ebaf728ff5 35 fields · synced Jul 8, 2026
- FDA UDI e068a3b8-c18f-4d5d-9622-d201b21841a3 35 fields · synced May 30, 2026
- EUDAMED 51d3a03e-866d-46a4-94e0-dfb069367b12 61 fields · synced Jul 8, 2026