Cleared Traditional

Y-KNOT ALL-SUTURE ANCHOR MODEL HF13

K111779 · Conmed Linvatec · Orthopedic
Aug 2011
Decision
45d
Days
Class 2
Risk

About This 510(k) Submission

K111779 is an FDA 510(k) clearance for the Y-KNOT ALL-SUTURE ANCHOR MODEL HF13, a Fastener, Fixation, Nondegradable, Soft Tissue (Class II — Special Controls, product code MBI), submitted by Conmed Linvatec (Largo, US). The FDA issued a Cleared decision on August 8, 2011, 45 days after receiving the submission on June 24, 2011. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K111779 FDA.gov
FDA Decision Cleared SESE
Date Received June 24, 2011
Decision Date August 08, 2011
Days to Decision 45 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code MBI — Fastener, Fixation, Nondegradable, Soft Tissue
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3040