Identity
- Trade Name
- SPII Model Lubinus FDA UDI
- Generic Name
- Uncoated hip femur prosthesis, modular FDA UDI
- Device Name
- Hip Prosthesis Stem - XL long neck,Taper 12/14 FDA UDI
- Model / Reference
- 127-740/26 FDA UDI
- Description
- Hip Prosthesis Stem - XL long neck,Taper 12/14 FDA UDI
Identifiers
- Catalog Number
- 127-740/26 FDA UDI
- Primary DI / UDI-DI
- 04026575241637 FDA UDI
- 510(k) Number
- K953653 FDA UDI
- FDA Product Code
- JDG FDA UDI
- GMDN Term
- Uncoated hip femur prosthesis, modular 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: Uncoated hip femur prosthesis, modular
SPII Model Lubinus by WALDEMAR LINK GmbH & Co. KG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Uncoated hip femur prosthesis, modular.
- Accolade — Howmedica Osteonics Corp. · Class II
- SUMMIT — DEPUY ORTHOPAEDICS, INC. · Class II
- S-ROM — DEPUY ORTHOPAEDICS, INC. · Class III
- Corin Taper-Fit Total Hip System — CORIN LTD · Class II
- TaperFit Cemented Hip System — CORIN LTD · Class II
- Omnifit — Howmedica Osteonics Corp. · Class II
- SUMMIT — DEPUY ORTHOPAEDICS, INC. · Class II
- Omnifit — Howmedica Osteonics Corp. · 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 7e0f4887-f6d6-42b1-ac84-4f35d5fca169 35 fields · synced May 30, 2026