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FDA 510(k)

PROFUSION BONE VOID FILLER

K-Number: K973704 · 1998-04-03

ApplicantBiogeneration
Decision Date1998-04-03
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PROFUSION BONE VOID FILLER is the device name listed in this FDA 510(k) record. The listed applicant is Biogeneration. It received FDA 510(k) clearance on 1998-04-03 under 510(k) number K973704. 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 PROFUSION BONE VOID FILLER?

PROFUSION BONE VOID FILLER is a medical device that received FDA 510(k) clearance on 1998-04-03. The listed applicant is Biogeneration. The 510(k) number is K973704.

When did PROFUSION BONE VOID FILLER receive FDA 510(k) clearance?

PROFUSION BONE VOID FILLER received FDA 510(k) clearance on 1998-04-03, under 510(k) number K973704.

Who is the listed applicant for PROFUSION BONE VOID FILLER?

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

What is the FDA product code for PROFUSION BONE VOID FILLER?

The FDA product code for PROFUSION BONE VOID FILLER is MQV.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Biogeneration 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.

K031838PROFUSION BONE VOID FILLER KIT

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

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

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