Cleared Special

SUPER REVO HERCULINE SUTURE ANCHOR

K041713 · Linvatec Corp. · Orthopedic
Jul 2004
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K041713 is an FDA 510(k) clearance for the SUPER REVO HERCULINE SUTURE ANCHOR, a Fastener, Fixation, Nondegradable, Soft Tissue (Class II — Special Controls, product code MBI), submitted by Linvatec Corp. (Largo, US). The FDA issued a Cleared decision on July 22, 2004, 29 days after receiving the submission on June 23, 2004. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K041713 FDA.gov
FDA Decision Cleared SESE
Date Received June 23, 2004
Decision Date July 22, 2004
Days to Decision 29 days
Submission Type Special
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