Cleared Traditional

STIMULAN KIT, STIMULAN RAPID CURE

K141830 · Biocomposites, Ltd. · Orthopedic
Jan 2015
Decision
200d
Days
Class 2
Risk

About This 510(k) Submission

K141830 is an FDA 510(k) clearance for the STIMULAN KIT, STIMULAN RAPID CURE, 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 January 23, 2015, 200 days after receiving the submission on July 7, 2014. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3045.

Submission Details

510(k) Number K141830 FDA.gov
FDA Decision Cleared SESE
Date Received July 07, 2014
Decision Date January 23, 2015
Days to Decision 200 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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