Cleared Special

THREVO ANCHOR, DISPOSABLE DRIVER, HI-FI SUTURES

K073481 · Conmed Linvatec · Orthopedic
Jan 2008
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K073481 is an FDA 510(k) clearance for the THREVO ANCHOR, DISPOSABLE DRIVER, HI-FI SUTURES, 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 January 7, 2008, 27 days after receiving the submission on December 11, 2007. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K073481 FDA.gov
FDA Decision Cleared SESE
Date Received December 11, 2007
Decision Date January 07, 2008
Days to Decision 27 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