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)

BI-OSTETIC FOAM AND PUTTY, GENEROS FOAM AND PUTTY

K-Number: K092046 · 2010-03-24

ApplicantBerkeley Advanced Biomaterials, Inc.
Decision Date2010-03-24
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BI-OSTETIC FOAM AND PUTTY, GENEROS FOAM AND PUTTY is the device name listed in this FDA 510(k) record. The listed applicant is Berkeley Advanced Biomaterials, Inc.. It received FDA 510(k) clearance on 2010-03-24 under 510(k) number K092046. 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 BI-OSTETIC FOAM AND PUTTY, GENEROS FOAM AND PUTTY?

BI-OSTETIC FOAM AND PUTTY, GENEROS FOAM AND PUTTY is a medical device that received FDA 510(k) clearance on 2010-03-24. The listed applicant is Berkeley Advanced Biomaterials, Inc.. The 510(k) number is K092046.

When did BI-OSTETIC FOAM AND PUTTY, GENEROS FOAM AND PUTTY receive FDA 510(k) clearance?

BI-OSTETIC FOAM AND PUTTY, GENEROS FOAM AND PUTTY received FDA 510(k) clearance on 2010-03-24, under 510(k) number K092046.

Who is the listed applicant for BI-OSTETIC FOAM AND PUTTY, GENEROS FOAM AND PUTTY?

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

What is the FDA product code for BI-OSTETIC FOAM AND PUTTY, GENEROS FOAM AND PUTTY?

The FDA product code for BI-OSTETIC FOAM AND PUTTY, GENEROS FOAM AND PUTTY 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 Berkeley Advanced Biomaterials, 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.

K113791B-GENIN, R-GENINK091912B-GENIN AND R-GENINK053213BI-OSTETIC FOAM, CEM-OSTETIC FOAM, TRI-OSTETIC FOAM, GENEROS FOAMK051914GENEROS 80, GENEROS 60K051695MARROW PLUS (M+)K050666GENEROS, MODELS GO-01G, GO-05G, GO-10G, GO-15G, GO-20G, GO-30G, GO-40G, GO-60G, GO-XYZ SERIES, GO-DZ SERIES

View all 13 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.

↑