Cleared Traditional

GENEX PUTTY

K073341 · Biocomposites, Ltd. · Orthopedic
Jul 2008
Decision
224d
Days
Class 2
Risk

About This 510(k) Submission

K073341 is an FDA 510(k) clearance for the GENEX PUTTY, a Filler, Bone Void, Calcium Compound (Class II — Special Controls, product code MQV), submitted by Biocomposites, Ltd. (Keele, GB). The FDA issued a Cleared decision on July 9, 2008, 224 days after receiving the submission on November 28, 2007. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3045.

Submission Details

510(k) Number K073341 FDA.gov
FDA Decision Cleared SESE
Date Received November 28, 2007
Decision Date July 09, 2008
Days to Decision 224 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code MQV — Filler, Bone Void, Calcium Compound
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3045

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