Cleared Traditional

PLC SUTURE ANCHOR

K063726 · Smith & Nephew Inc., Endoscopy Div. · Orthopedic
Mar 2007
Decision
81d
Days
Class 2
Risk

About This 510(k) Submission

K063726 is an FDA 510(k) clearance for the PLC SUTURE ANCHOR, a Plate, Fixation, Bone (Class II — Special Controls, product code HRS), submitted by Smith & Nephew Inc., Endoscopy Div. (Andover, US). The FDA issued a Cleared decision on March 6, 2007, 81 days after receiving the submission on December 15, 2006. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K063726 FDA.gov
FDA Decision Cleared SESE
Date Received December 15, 2006
Decision Date March 06, 2007
Days to Decision 81 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HRS — Plate, Fixation, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3030

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