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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 a medical device manufactured by Biocomposites, Ltd.. It received FDA 510(k) clearance on 2022-02-04 under approval 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. It is manufactured by Biocomposites, Ltd.. The 510(k) number is K212721.

When was Genex Bone Graft Substitute approved by the FDA?

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

What company makes Genex Bone Graft Substitute?

Genex Bone Graft Substitute is manufactured by Biocomposites, Ltd..

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

NCT01234415 Bone Substitute in the Multi Traumatized Nasal Septum Reconstruction COMPLETED NCT07059065 FIBERGRAFT Aeridyan Posterolateral Fusion Study RECRUITING NCT07569146 Assessment of Deproteinized Bovine Bone for Immediate Implants Placement in Maxillary Esthetic Zone. COMPLETED NCT05706909 The Use of Genex in the Management of Early-Stage Osteonecrosis of the Femoral Head ACTIVE_NOT_RECRUITING

Other Devices by Biocomposites, Ltd.

K242865Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder Spacer K250521NanoBone® SBX Putty ; NanoBone® QD K251680Biosteon® Screw

Related Devices (Code: MQV)

K160566Cerasorb Ortho FoamCurasan AG K160446MCP Bone PuttyBiostructures, LLC K161351NanoBone SBX PuttyArtoss GmbH K161447HydroSet XTOrthovita, Inc. K152077MaxiGenHans Biomed Corp. K151271BellaFuseHans Biomed Corp.

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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