Cleared Traditional

ULTRAFIX KNOTLESS MINIMITE SUTURE ANCHOR

K022827 · Linvatec Corp. · Orthopedic
Nov 2002
Decision
88d
Days
Class 2
Risk

About This 510(k) Submission

K022827 is an FDA 510(k) clearance for the ULTRAFIX KNOTLESS MINIMITE 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 November 22, 2002, 88 days after receiving the submission on August 26, 2002. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K022827 FDA.gov
FDA Decision Cleared SESE
Date Received August 26, 2002
Decision Date November 22, 2002
Days to Decision 88 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