Identity
- Trade Name
- C-STEM FDA UDI
- Generic Name
- Uncoated hip femur prosthesis, modular FDA UDI
- Device Name
- C-STEM Stem SIZE 8 9/10 TAPER CEMENTED FDA UDI
- Model / Reference
- 9611-68-000 FDA UDI
- Description
- C-STEM Stem SIZE 8 9/10 TAPER CEMENTED FDA UDI
Identifiers
- Catalog Number
- 961168000 FDA UDI
- Primary DI / UDI-DI
- 10603295235255 FDA UDI
- 510(k) Number
- K982918 FDA UDI
- FDA Product Code
- JDI FDA UDI
- GMDN Term
- Uncoated hip femur prosthesis, modular FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3350 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
C-Stem by Depuy (ireland) — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
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
- Depuy (ireland)
Sources (1)
- FDA UDI e6f52649-40b2-41f6-af5a-d5ef2147f2ea 37 fields · synced May 31, 2026