Genex

FDA 510(k) K082381 · Biocomposites, Ltd.

Substantially Equivalent

510(k) numberK082381

Submission

Device name
Genex
Applicant
Biocomposites, Ltd.
Keele, GB
Received
August 19, 2008
Decision date
November 14, 2008
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MQV – Filler, Bone Void, Calcium Compound
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3045
Specialty
Orthopedic
Implant
Yes

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K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft…MQV · Special Prosidyan, Inc.10/22/2025SE
K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™MQV · Traditional Bone Solutions, Inc.10/13/2025SE
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K251720OsteoFlo HydroFiberMQV · Special SurGenTec, LLC07/02/2025SE

More from SurGenTec, LLC

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K251680Biosteon® ScrewMAI · Traditional 02/17/2026SE
K242865Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder SpacerKWL · Traditional 06/12/2025SE
K250521NanoBone® SBX Putty ; NanoBone® QDMQV · Traditional 04/07/2025SE
K212721Genex Bone Graft SubstituteMQV · Traditional 02/04/2022SE
K141830Stimulan Kit, Stimulan Rapid CureMQV · Traditional 01/23/2015SE
K082383Fortoss VitalLYC · Special 09/05/2008SE
K073341Genex PuttyMQV · Traditional 07/09/2008SE
K081428Modification to Doubleplay Suture AnchorHWC · Special 06/20/2008SE
K072127DominatorHWC · Special 08/31/2007SE
K071952Graftlock Screw, ST ScrewHWC · Special 08/14/2007SE

Questions and answers

When was Genex cleared by the FDA?

Genex (K082381) received a 510(k) decision of Substantially Equivalent on November 14, 2008, 87 days after the submission was received.

What is the product code of K082381?

The FDA product code is MQV – Filler, Bone Void, Calcium Compound, a Class II (moderate risk) device regulated under 21 CFR 888.3045.