AUGMENT BONE GRAFT
FDA premarket approval P100006 · decided 2015-09-01
Approval details
- PMA number
- P100006
- Trade name
- AUGMENT BONE GRAFT
- Generic name
- Filler, bone void, synthetic peptide
- Applicant
- Biomimetic Therapeutics, LLC
- Date received
- 2010-02-04
- Decision date
- 2015-09-01
- Days to decision
- 2035 days
- Decision code
- APPR
- Product code
- NOX
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Franklin, TN
- Statement
- APPROVAL FOR AUGMENT® BONE GRAFT. THIS DEVICE IS INDICATED FOR USE AS AN ALTERNATIVE TO AUTOGRAFT IN ARTHRODESIS (I.E., SURGICAL FUSION PROCEDURES) OF THE ANKLE (TIBIOTALAR JOINT) AND/OR HINDFOOT (INCLUDING SUBTALAR, TALONAVICULAR, AND CALCANEOCUBOID JOINTS, ALONE OR IN COMBINATION), DUE TO OSTEOARTHRITIS, POST-TRAUMATIC ARTHRITIS, RHEUMATOID ARTHRITIS, PSORIATIC ARTHRITIS, AVASCULAR NECROSIS, JOINT INSTABILITY, JOINT DEFORMITY, CONGENITAL DEFECT, OR JOINT ARTHROPATHY IN PATIENTS WITH PREOPERATI
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