Cleared Traditional

SUTURE ARROW

K041128 · Linvatec Corp. · Orthopedic
Jul 2004
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K041128 is an FDA 510(k) clearance for the SUTURE ARROW, a Fastener, Fixation, Biodegradable, Soft Tissue (Class II — Special Controls, product code MAI), submitted by Linvatec Corp. (Largo, US). The FDA issued a Cleared decision on July 29, 2004, 90 days after receiving the submission on April 30, 2004. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K041128 FDA.gov
FDA Decision Cleared SESE
Date Received April 30, 2004
Decision Date July 29, 2004
Days to Decision 90 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code MAI — Fastener, Fixation, Biodegradable, Soft Tissue
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3030

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