SpineAR SNAP
SpineAR SNAP is a surgical planning/navigation-enhancement system (FDA Class II) made by Surgical Theater LLC, cleared under FDA 510(k) K213034 on 29 Sep 2022 and listed in FDA GUDID since 23 Jun 2023 (UDI-DI 00860003884126), active as of 1 Jun 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 | Number00860003884126 | Date23 Jun 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK213034 | Date29 Sep 2022 | StatusActive |
Official records
- AccessGUDID record 00860003884126
- FDA 510(k) database K213034
Across registries
- FDA 510(k) K213034 decided 29 Sep 2022 Active
- FDA GUDID UDI-DI 00860003884126 listed 23 Jun 2023 Listed
Timeline
- Cleared FDA 510(k) K213034
- Listed FDA GUDID 00860003884126
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Surgical planning/navigation-enhancement system
- Model / reference
- SpineAR
- Primary DI / UDI-DI
- 00860003884126
- 510(k) Number
- FDA product code
- LLZ, OLO
- GMDN term
- Surgical planning/navigation-enhancement system
- Device class
- Class II
- Regulation number
- 892.2050, 882.4560
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Surgical planning/navigation-enhancement system.