MOBIO Total Knee System
FDA 510(k) clearance K210483 · decided 2021-04-21
Clearance details
- K-number
- K210483
- Device name
- MOBIO Total Knee System
- Applicant
- B-One Ortho, Corp.
- Decision
- Substantially Equivalent
- Date received
- 2021-02-19
- Decision date
- 2021-04-21
- Days to decision
- 61 days
- Clearance type
- Traditional
- Product code
- JWH
- Device class
- 2
- Regulation number
- 888.3560
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Cedar Knolls, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.