MISHA Knee System
FDA 510(k) clearance DEN220033 · decided 2023-04-10
Clearance details
- K-number
- DEN220033
- Device name
- MISHA Knee System
- Applicant
- Moximed, Inc.
- Decision
- Unknown
- Date received
- 2022-06-06
- Decision date
- 2023-04-10
- Days to decision
- 308 days
- Clearance type
- Direct
- Product code
- QVV
- Device class
- 2
- Regulation number
- 888.3610
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Fremont, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.