Navigation Instruments 682.921
Navigation Instruments 682.921 is a Class II device made by Globus Medical, Inc., cleared under FDA 510(k) K180690 on 25 Jun 2018 and listed in FDA GUDID since 27 Jun 2019 (UDI-DI 00889095717211), 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 | Number00889095717211 | Date27 Jun 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK180690 | Date25 Jun 2018 | StatusActive |
Official records
- AccessGUDID record 00889095717211
- FDA 510(k) database K180690
Across registries
- FDA 510(k) K180690 decided 25 Jun 2018 Active
- FDA GUDID UDI-DI 00889095717211 listed 27 Jun 2019 Listed
Timeline
- Cleared FDA 510(k) K180690
- Listed FDA GUDID 00889095717211
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Navigation Instruments
- Generic name
- Orthopaedic surgical procedure kit, non-medicated, reusable
- Model / reference
- 682.921
- Primary DI / UDI-DI
- 00889095717211
- 510(k) Number
- FDA product code
- OLO
- GMDN term
- Orthopaedic surgical procedure kit, non-medicated, reusable
- Device class
- Class II
- Regulation number
- 882.4560
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
Similar devices in this category
Other devices filed under Orthopaedic surgical procedure kit, non-medicated, reusable.