Cleared Traditional

K070780 - CONMED LINVATEC XO BUTTON
(FDA 510(k) Clearance)

K070780 · Conmed Linvatec · Orthopedic
Aug 2007
Decision
153d
Days
Class 2
Risk

K070780 is an FDA 510(k) clearance for the CONMED LINVATEC XO BUTTON, 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 21, 2007, 153 days after receiving the submission on March 21, 2007. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K070780 FDA.gov
FDA Decision Cleared SESE
Date Received March 21, 2007
Decision Date August 21, 2007
Days to Decision 153 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