ChoiceSpine Navigation System
FDA 510(k) clearance K220024 · decided 2022-07-06
Clearance details
- K-number
- K220024
- Device name
- ChoiceSpine Navigation System
- Applicant
- Choice Spine, LLC
- Decision
- Substantially Equivalent
- Date received
- 2022-01-05
- Decision date
- 2022-07-06
- Days to decision
- 182 days
- Clearance type
- Traditional
- Product code
- OLO
- Device class
- 2
- Regulation number
- 882.4560
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Knoxville, TN, US
- Third-party review
- No
- Expedited review
- No
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| VERTICALE® Navigation Instruments (K253921) | Silony Medical GmbH | 2026-06-26 |
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Recalls involving this device
No recalls on record reference this clearance.