MIS Precision Chevron Bunion System
FDA 510(k) clearance K211628 · decided 2022-01-31
Clearance details
- K-number
- K211628
- Device name
- MIS Precision Chevron Bunion System
- Applicant
- Relja Innovations, LLC
- Decision
- Substantially Equivalent
- Date received
- 2021-05-27
- Decision date
- 2022-01-31
- Days to decision
- 249 days
- Clearance type
- Traditional
- Product code
- HWC
- Device class
- 2
- Regulation number
- 888.3040
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Brookfield, WI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.