Revision Knee System 2970-0-0027
by Shalby Advanced Technologies, Inc.
Revision Knee System 2970-0-0027 is a Class I device made by Shalby Advanced Technologies, Inc., listed in FDA GUDID since 22 May 2025 (UDI-DI 00840286842068), registry data as of 23 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00840286842068 | Date22 May 2025 | StatusListed |
Official records
- AccessGUDID record 00840286842068
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Revision Knee System
- Generic name
- Fluted surgical drill bit, reusable
- Model / Ref / Catalog
- 2970-0-0027
- Primary DI / UDI-DI
- 00840286842068
- FDA product code
- KIJ
- GMDN term
- Fluted surgical drill bit, reusable
- Device class
- Class I
- Regulation number
- 878.4820
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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