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FDA 510(k)

POLYGRAFT BGS; BONE GRAFT SUBSTITUTE

K-Number: K040047 · 2004-12-17

ApplicantOsteobiologics, Inc.
Decision Date2004-12-17
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

POLYGRAFT BGS; BONE GRAFT SUBSTITUTE is the device name listed in this FDA 510(k) record. The listed applicant is Osteobiologics, Inc.. It received FDA 510(k) clearance on 2004-12-17 under 510(k) number K040047. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POLYGRAFT BGS; BONE GRAFT SUBSTITUTE?

POLYGRAFT BGS; BONE GRAFT SUBSTITUTE is a medical device that received FDA 510(k) clearance on 2004-12-17. The listed applicant is Osteobiologics, Inc.. The 510(k) number is K040047.

When did POLYGRAFT BGS; BONE GRAFT SUBSTITUTE receive FDA 510(k) clearance?

POLYGRAFT BGS; BONE GRAFT SUBSTITUTE received FDA 510(k) clearance on 2004-12-17, under 510(k) number K040047.

Who is the listed applicant for POLYGRAFT BGS; BONE GRAFT SUBSTITUTE?

The FDA 510(k) record lists Osteobiologics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for POLYGRAFT BGS; BONE GRAFT SUBSTITUTE?

The FDA product code for POLYGRAFT BGS; BONE GRAFT SUBSTITUTE is MQV.

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Other records listing Osteobiologics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K051656OCT (OSTEOCHONDRAL TRANSPLANT) COMPREHENSIVE SYSTEMK041382POLYGRAFT BGS; BONE GRAFT SUBSTITUTEK043172TRUGRAFT BGS SYRINGE, MODEL 600-041K033707POLYGRAFT TCP GRANULES, CUBES, BLOCKS, PLUGS, WEDGES, MODELS 600-023-XX, 600-025-XX, 600-026-XX, 600-022-XX, 600-027-XXK032673IMMIX PLASTIFILMK030288POLYGRAFT BONE GRAFT SUBSTITUTE

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Related Devices (Code: MQV)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262230Mg OSTEOREVIVE™;Mg OSTEOCRETE™Bone Solutions, Inc.K260364Device 300419 StripGeistlich Pharma AGK252797JAZBI™ Resorbable Bone Void FillerSdip Innovations Pty, Ltd.K261008Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip; Vitoss® BiModal Bioactive Bone Graft Substitute; Vitoss BBTrauma® Bioactive Bone Graft Substitute; Vitoss® BA2X Bioactive Bone Graft Substitute; Vitoss® Bioactive Foam Bone Graft Substitute Pack; Vitoss® Bioactive Foam Bone Graft Substitute; Vitoss® Foam Bone Graft Substitute; Vitoss® Bone Graft Substitute Filled Canister; Vitoss® Bone Graft SubstituteStryker SpineK253524Adaptos®Fuse Bone GraftBiomendex OYK253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft Substitute FIBERGRAFT™ AERIDYAN™ Matrix Bone Graft Substitute FIBERGRAFT™ BG Matrix Bone Graft SubstituteProsidyan, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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