Identity
- Trade Name
- SPII Model Lubinus FDA UDI
- Generic Name
- Revision uncoated hip femur prosthesis FDA UDI
- Device Name
- XL Hip Prosthesis Stem,Taper 12/14 FDA UDI
- Model / Reference
- 127-930/35 FDA UDI
- Description
- XL Hip Prosthesis Stem,Taper 12/14 FDA UDI
Identifiers
- Catalog Number
- 127-930/35 FDA UDI
- Primary DI / UDI-DI
- 04026575025480 FDA UDI
- 510(k) Number
- K953653 FDA UDI
- FDA Product Code
- JDG FDA UDI
- GMDN Term
- Revision uncoated hip femur prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3360 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: Revision uncoated hip femur prosthesis
SPII Model Lubinus by WALDEMAR LINK GmbH & Co. KG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Revision uncoated hip femur prosthesis.
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- Alteon — Exactech, Inc. · Class II
- ZMR® — Zimmer, Inc. · Class II
- Wagner SL Revision® — Zimmer, Inc. · Class II
- ZMR® — Zimmer, Inc. · Class II
- Wagner Cone Prosthesis® — Zimmer, Inc. · 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 (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 99f18689-d7e7-4ea3-97da-23e410e32fc3 35 fields · synced Jun 8, 2026