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FDA 510(k)

Genex Bone Graft Substitute

K-Number: K212721 · 2022-02-04

ApplicantBiocomposites, Ltd.
Decision Date2022-02-04
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Genex Bone Graft Substitute is the device name listed in this FDA 510(k) record. The listed applicant is Biocomposites, Ltd.. It received FDA 510(k) clearance on 2022-02-04 under 510(k) number K212721. 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 Bone Graft Substitute?

Genex Bone Graft Substitute is a medical device that received FDA 510(k) clearance on 2022-02-04. The listed applicant is Biocomposites, Ltd.. The 510(k) number is K212721.

When did Genex Bone Graft Substitute receive FDA 510(k) clearance?

Genex Bone Graft Substitute received FDA 510(k) clearance on 2022-02-04, under 510(k) number K212721.

Who is the listed applicant for Genex Bone Graft Substitute?

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 Bone Graft Substitute?

The FDA product code for Genex Bone Graft Substitute 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.

NCT07270380Antibiotic Device for Osteomyelitis of the Extremities Pivotal Trial - Genex With Gentamicin.RECRUITINGNCT05706909The Use of Genex in the Management of Early-Stage Osteonecrosis of the Femoral HeadACTIVE_NOT_RECRUITINGNCT01234415Bone Substitute in the Multi Traumatized Nasal Septum ReconstructionCOMPLETEDNCT07057817The ACHILLS Trial; Application of Cerament in Heel Infection for Lower Limb SalvageRECRUITINGNCT07059065FIBERGRAFT Aeridyan Posterolateral Fusion StudyRECRUITINGNCT07569146Assessment of Deproteinized Bovine Bone for Immediate Implants Placement in Maxillary Esthetic Zone.COMPLETED

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® QD

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.

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.K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, 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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