MCP Bone Putty
FDA 510(k) clearance K160446 · decided 2016-11-07
Clearance details
- K-number
- K160446
- Device name
- MCP Bone Putty
- Applicant
- Biostructures, LLC
- Decision
- Substantially Equivalent
- Date received
- 2016-02-17
- Decision date
- 2016-11-07
- Days to decision
- 264 days
- Clearance type
- Traditional
- Product code
- MQV
- Device class
- 2
- Regulation number
- 888.3045
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Newport Beach, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.