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FDA 510(k)

OSSIFUSE BONE SUBSTITUTE MATERIAL

K-Number: K072355 · 2007-09-26

ApplicantEtex Corp.
Decision Date2007-09-26
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OSSIFUSE BONE SUBSTITUTE MATERIAL is the device name listed in this FDA 510(k) record. The listed applicant is Etex Corp.. It received FDA 510(k) clearance on 2007-09-26 under 510(k) number K072355. 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 OSSIFUSE BONE SUBSTITUTE MATERIAL?

OSSIFUSE BONE SUBSTITUTE MATERIAL is a medical device that received FDA 510(k) clearance on 2007-09-26. The listed applicant is Etex Corp.. The 510(k) number is K072355.

When did OSSIFUSE BONE SUBSTITUTE MATERIAL receive FDA 510(k) clearance?

OSSIFUSE BONE SUBSTITUTE MATERIAL received FDA 510(k) clearance on 2007-09-26, under 510(k) number K072355.

Who is the listed applicant for OSSIFUSE BONE SUBSTITUTE MATERIAL?

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

What is the FDA product code for OSSIFUSE BONE SUBSTITUTE MATERIAL?

The FDA product code for OSSIFUSE BONE SUBSTITUTE MATERIAL is MQV.

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Other records listing Etex Corp. as applicant

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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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