Cleared Traditional

ALLOGRAN-R

K061311 · Biocomposites, Ltd. · Orthopedic
Sep 2006
Decision
135d
Days
Class 2
Risk

About This 510(k) Submission

K061311 is an FDA 510(k) clearance for the ALLOGRAN-R, 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 September 22, 2006, 135 days after receiving the submission on May 10, 2006. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3045.

Submission Details

510(k) Number K061311 FDA.gov
FDA Decision Cleared SESE
Date Received May 10, 2006
Decision Date September 22, 2006
Days to Decision 135 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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