Mg OSTEOINJECT
FDA 510(k) clearance K221256 · decided 2022-06-28
Clearance details
- K-number
- K221256
- Device name
- Mg OSTEOINJECT
- Applicant
- Bone Solutions, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2022-05-02
- Decision date
- 2022-06-28
- Days to decision
- 57 days
- Clearance type
- Traditional
- Product code
- MQV
- Device class
- 2
- Regulation number
- 888.3045
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Colleyville, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.