Identity
- Trade Name
- Revision Knee System FDA UDI
- Generic Name
- Revision coated hip femur prosthesis FDA UDI
- Device Name
- Stem, Straight, Cementless, 10mm, 110mm FDA UDI
- Model / Reference
- 2461-0-1110 FDA UDI
- Description
- Stem, Straight, Cementless, 10mm, 110mm FDA UDI
Identifiers
- Catalog Number
- 2461-0-1110 FDA UDI
- Primary DI / UDI-DI
- 00840286823562 FDA UDI
- FDA Product Code
- JWH FDA UDI
- GMDN Term
- Revision coated hip femur prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3560 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
Yes
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 coated hip femur prosthesis
Revision Knee System by Shalby Advanced Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Shalby Advanced Technologies, Inc.
Sources (1)
- FDA UDI 9551877a-fbbb-48b2-897d-760218d77c07 35 fields · synced May 31, 2026