FINE Osteotomy
FDA 510(k) clearance K211646 · decided 2021-07-28
Clearance details
- K-number
- K211646
- Device name
- FINE Osteotomy
- Applicant
- Bodycad Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2021-05-28
- Decision date
- 2021-07-28
- Days to decision
- 61 days
- Clearance type
- Traditional
- Product code
- HRS
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Quebec City, CA
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.