Cleared Traditional

DOUBLEPLAY SUTURE ANCHOR

K061949 · Biocomposites, Ltd. · Orthopedic
Sep 2006
Decision
77d
Days
Class 2
Risk

About This 510(k) Submission

K061949 is an FDA 510(k) clearance for the 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 September 25, 2006, 77 days after receiving the submission on July 10, 2006. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K061949 FDA.gov
FDA Decision Cleared SESE
Date Received July 10, 2006
Decision Date September 25, 2006
Days to Decision 77 days
Submission Type Traditional
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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