Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

GENEX

K-Number: K082381 · 2008-11-14

ApplicantBiocomposites, Ltd.
Decision Date2008-11-14
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

GENEX is the device name listed in this FDA 510(k) record. The listed applicant is Biocomposites, Ltd.. It received FDA 510(k) clearance on 2008-11-14 under 510(k) number K082381. 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 GENEX?

GENEX is a medical device that received FDA 510(k) clearance on 2008-11-14. The listed applicant is Biocomposites, Ltd.. The 510(k) number is K082381.

When did GENEX receive FDA 510(k) clearance?

GENEX received FDA 510(k) clearance on 2008-11-14, under 510(k) number K082381.

Who is the listed applicant for GENEX?

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

What is the FDA product code for GENEX?

The FDA product code for GENEX 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 Biocomposites, Ltd. 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.

K251680Biosteon® ScrewK242865Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder SpacerK250521NanoBone® SBX Putty ; NanoBone® QDK212721Genex Bone Graft SubstituteK082383FORTOSS VITALK073341GENEX PUTTY

View all 26 devices →

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.

↑