Cleared Special

HI-FI ULTRAFIX KNOTLESS MINIMITE SUTURE ANCHOR

K060714 · Conmed Linvatec · Orthopedic
Apr 2006
Decision
20d
Days
Class 2
Risk

About This 510(k) Submission

K060714 is an FDA 510(k) clearance for the HI-FI ULTRAFIX KNOTLESS MINIMITE SUTURE ANCHOR, a Screw, Fixation, Bone (Class II — Special Controls, product code HWC), submitted by Conmed Linvatec (Largo, US). The FDA issued a Cleared decision on April 6, 2006, 20 days after receiving the submission on March 17, 2006. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K060714 FDA.gov
FDA Decision Cleared SESE
Date Received March 17, 2006
Decision Date April 06, 2006
Days to Decision 20 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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