SPII Model Lubinus
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- SPII Model Lubinus FDA UDI
- Generic Name
- Uncoated hip femur prosthesis, modular FDA UDI
- Device Name
- SPII Model Lubinus Hip Stem EUDAMEDHip Prosthesis Stem,Taper 12/14 FDA UDI
- Model / Reference
- 127-628/17 EUDAMEDFDA UDIHip stem, cemented, CoCrMo, standard neck, CCD 117° EUDAMED
- Description
- Hip Prosthesis Stem,Taper 12/14 FDA UDI
Identifiers
- Catalog Number
- 127-628/17 FDA UDI
- Primary DI / UDI-DI
- 04026575387250 EUDAMEDFDA UDI
- Basic UDI-DI
- 4026575-1-HSP-003001-VM EUDAMED
- 510(k) Number
- K953653 FDA UDI
- FDA Product Code
- JDG FDA UDI
- EMDN Code
- P090804010102 CEMENTED FEMORAL STEMS FOR PRIMARY IMPLANT, WITH FIXED NECK, ANATOMICAL EUDAMED
- GMDN Term
- Uncoated hip femur prosthesis, modular 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: Uncoated hip femur prosthesis, modular
SPII Model Lubinus 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 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 (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 (2)
- FDA UDI ac49286a-dbbe-45b1-b20a-27da10ac7f77 35 fields · synced Oct 9, 2026
- EUDAMED e6d19fad-008c-4494-b37a-f92262167687 61 fields · synced Oct 9, 2026