Cleared Special

THREVO SUTURE ANCHOR WITH DISPOSABLE DRIVER

K050227 · Linvatec Corp. · Orthopedic
Mar 2005
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K050227 is an FDA 510(k) clearance for the THREVO SUTURE ANCHOR WITH DISPOSABLE DRIVER, 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 March 2, 2005, 29 days after receiving the submission on February 1, 2005. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K050227 FDA.gov
FDA Decision Cleared SESE
Date Received February 01, 2005
Decision Date March 02, 2005
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