Cleared Traditional

GENEX

K082381 · Biocomposites, Ltd. · Orthopedic
Nov 2008
Decision
87d
Days
Class 2
Risk

About This 510(k) Submission

K082381 is an FDA 510(k) clearance for the GENEX, 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 November 14, 2008, 87 days after receiving the submission on August 19, 2008. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3045.

Submission Details

510(k) Number K082381 FDA.gov
FDA Decision Cleared SESE
Date Received August 19, 2008
Decision Date November 14, 2008
Days to Decision 87 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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