GENERIC Surgical Instruments 059.7047
GENERIC Surgical Instruments 059.7047 is a Class I device made by CTL Medical Corporation, cleared under FDA 510(k) K162160 on 18 Nov 2016 and listed in FDA GUDID since 13 Sep 2023 (UDI-DI 00841732134232), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00841732134232 | Date13 Sep 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK162160 | Date18 Nov 2016 | StatusActive |
Official records
- AccessGUDID record 00841732134232
- FDA 510(k) database K162160
Across registries
- FDA 510(k) K162160 decided 18 Nov 2016 Active
- FDA GUDID UDI-DI 00841732134232 listed 13 Sep 2023 Listed
Timeline
- Cleared FDA 510(k) K162160
- Listed FDA GUDID 00841732134232
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- GENERIC Surgical Instruments
- Generic name
- Bone-resection orthopaedic reamer, reusable
- Model / reference
- 059.7047
- Primary DI / UDI-DI
- 00841732134232
- FDA product code
- LXH
- GMDN term
- Bone-resection orthopaedic reamer, reusable
- Device class
- Class I
- Regulation number
- 888.4540
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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