Identity
- Trade Name
- Revision Knee System FDA UDI
- Generic Name
- Knee femur prosthesis trial, reusable FDA UDI
- Device Name
- RKS, Trial, Plug, Taper FDA UDI
- Model / Reference
- 2970-0-0003 FDA UDI
- Description
- RKS, Trial, Plug, Taper FDA UDI
Identifiers
- Catalog Number
- 2970-0-0003 FDA UDI
- Primary DI / UDI-DI
- 00840286842457 FDA UDI
- FDA Product Code
- HWT FDA UDI
- GMDN Term
- Knee femur prosthesis trial, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Knee tibia prosthesis trial, reusableKnee femur prosthesis trial, reusable
Revision Knee System by Shalby Advanced Technologies, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Knee femur prosthesis trial, reusable.
- Lospa Modular Knee System — Corentec Co., Ltd · Class II
- OSS™ — Biomet Orthopedics, Inc. · Class II
- VANGUARD 360 INSTRUMENT — Biomet Orthopedics, Inc. · Class II
- VANGUARD(TM) PS FEMORAL TRIAL — Biomet Orthopedics, Inc. · Class II
- Natural-Knee® — Zimmer, Inc. · Class II
- NexGen® — Zimmer, Inc. · Class II
- LOSPA Knee System — Corentec Co., Ltd · Class II
- Persona® — Zimmer, Inc. · Class II
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 I | Pending data |
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Manufacturer
- Manufacturer
- Shalby Advanced Technologies, Inc.
Sources (1)
- FDA UDI 0cd436c1-a558-48d1-9d29-b6e50aaaf2cf 36 fields · synced May 31, 2026