Identity
- Trade Name
- REVISION HIP - UNCEMENTED STEM D.16 MM L.140 MM EUDAMEDREVISION FDA UDI
- Generic Name
- Revision uncoated femoral stem prosthesis FDA UDI
- Device Name
- Uncemented Stem Dia=16mm - L=140mm FDA UDI
- Model / Reference
- REVISION HIP EUDAMED3812.15.010 EUDAMEDREVISION HIP - Ti6Al4V FDA UDI
- Description
- Uncemented Stem Dia=16mm - L=140mm FDA UDI
Identifiers
- Catalog Number
- 3812.15.010 FDA UDI
- Primary DI / UDI-DI
- 08033390003865 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08033390003865 EUDAMED
- 510(k) Number
- K151739 FDA UDI
- FDA Product Code
- KWY FDA UDILPH FDA UDILZO FDA UDI
- EMDN Code
- P090804030202 REVISION UNCEMENTED FEMORAL STEMS, WITH MODULAR NECK EUDAMED
- GMDN Term
- Revision uncoated femoral stem prosthesis FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3390 FDA UDI888.3358 FDA UDI888.3353 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Revision uncoated femoral stem prosthesis
Revision by Limacorporate — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
K151739 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Limacorporate
Sources (2)
- FDA UDI cceddd56-b9f4-417c-bad8-2633fc7ff0f0 36 fields · synced Jul 13, 2026
- EUDAMED 9b367231-84e4-4fd6-a360-242aa1bfef0b 61 fields · synced Jul 13, 2026