Cleared Special

MODIFICATION TO DOUBLEPLAY SUTURE ANCHOR

K081428 · Biocomposites, Ltd. · Orthopedic
Jun 2008
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K081428 is an FDA 510(k) clearance for the MODIFICATION TO DOUBLEPLAY SUTURE ANCHOR, a Screw, Fixation, Bone (Class II — Special Controls, product code HWC), submitted by Biocomposites, Ltd. (Keele, GB). The FDA issued a Cleared decision on June 20, 2008, 30 days after receiving the submission on May 21, 2008. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K081428 FDA.gov
FDA Decision Cleared SESE
Date Received May 21, 2008
Decision Date June 20, 2008
Days to Decision 30 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HWC — Screw, Fixation, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3040

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