FDA 510(k) K040047, POLYGRAFT BGS; BONE GRAFT SUBSTITUTE, by Osteobiologics, Inc.
FDA 510(k) K040047, POLYGRAFT BGS; BONE GRAFT SUBSTITUTE, by Osteobiologics, Inc.
Device Classification Name: Filler, Bone Void, Calcium Compound
510(k) Number: K040047
Device Name: POLYGRAFT BGS; BONE GRAFT SUBSTITUTE
Applicant: Osteobiologics, Inc.
Regulation Number: 888.3045
Classification Product Code: MQV
Date Received: 2004-01-12
Decision Date: 2004-12-17
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
510k Review Panel: Orthopedic
Total number of pages: 125
Fully redacted pages: 42
Content pages: 83
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