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FDA 510(k)

PROFUSION BONE VOID FILLER KIT

K-Number: K031838 · 2003-10-30

ApplicantBiogeneration
Decision Date2003-10-30
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PROFUSION BONE VOID FILLER KIT is the device name listed in this FDA 510(k) record. The listed applicant is Biogeneration. It received FDA 510(k) clearance on 2003-10-30 under 510(k) number K031838. 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 KIT?

PROFUSION BONE VOID FILLER KIT is a medical device that received FDA 510(k) clearance on 2003-10-30. The listed applicant is Biogeneration. The 510(k) number is K031838.

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

PROFUSION BONE VOID FILLER KIT received FDA 510(k) clearance on 2003-10-30, under 510(k) number K031838.

Who is the listed applicant for PROFUSION BONE VOID FILLER KIT?

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 KIT?

The FDA product code for PROFUSION BONE VOID FILLER KIT 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.

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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.

K973704PROFUSION BONE VOID FILLER

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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