Cleared Traditional

STIMULAN - CALCIUM SULFATE BONE VOID FILLER KIT

K021551 · Biocomposites, Ltd. · Orthopedic
Nov 2002
Decision
172d
Days
Class 2
Risk

About This 510(k) Submission

K021551 is an FDA 510(k) clearance for the STIMULAN - CALCIUM SULFATE BONE VOID FILLER KIT, a Filler, Bone Void, Calcium Compound (Class II — Special Controls, product code MQV), submitted by Biocomposites, Ltd. (Stoke On Trent, GB). The FDA issued a Cleared decision on November 1, 2002, 172 days after receiving the submission on May 13, 2002. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3045.

Submission Details

510(k) Number K021551 FDA.gov
FDA Decision Cleared SESE
Date Received May 13, 2002
Decision Date November 01, 2002
Days to Decision 172 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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