Navigation Toolset GS005
Navigation Toolset GS005 is a Class II device made by Gyder Surgical Pty Ltd, cleared under FDA 510(k) K243387 on 29 Jan 2025 and listed in FDA GUDID since 18 Sep 2025 (UDI-DI 09360506000128), active as of 23 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 | Number09360506000128 | Date18 Sep 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK243387 | Date29 Jan 2025 | StatusActive |
Official records
- AccessGUDID record 09360506000128
- FDA 510(k) database K243387
Across registries
- FDA 510(k) K243387 decided 29 Jan 2025 Active
- FDA GUDID UDI-DI 09360506000128 listed 18 Sep 2025 Listed
Timeline
- Cleared FDA 510(k) K243387
- Listed FDA GUDID 09360506000128
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Navigation Toolset
- Generic name
- Orthopaedic surgical procedure kit, non-medicated, reusable
- Model / reference
- GS005
- Primary DI / UDI-DI
- 09360506000128
- 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
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