Choice Spine Navigation System
510(k) K182721
Choice Spine Navigation System is a Class II device made by Choicespine, LP, cleared under FDA 510(k) K182721 on 8 Jan 2019, 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 | FDA 510(k)SESE | NumberK182721 | Date8 Jan 2019 | StatusActive |
Official records
- FDA 510(k) database K182721
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- OLO
- Device class
- Class II
- Regulation
- 21 CFR Part 882.4560
- Advisory committee
- Neurology
- FDA decision
- SESE Substantially Equivalent
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