EquivaBone Osteoinductive Bone Graft Substitute (EquivaBone )
FDA 510(k) clearance K243609 · decided 2024-12-18
Clearance details
- K-number
- K243609
- Device name
- EquivaBone Osteoinductive Bone Graft Substitute (EquivaBone )
- Applicant
- Etex Corporation
- Decision
- Substantially Equivalent
- Date received
- 2024-11-22
- Decision date
- 2024-12-18
- Days to decision
- 26 days
- Clearance type
- Special
- Product code
- MQV
- Device class
- 2
- Regulation number
- 888.3045
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Braintree, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.