Cleared Traditional

ARTHROSURFACE KISSLOC KNOTLESS SUTURE SYSTEM

K133835 · Arthrosurface, Inc. · Orthopedic
Jul 2014
Decision
197d
Days
Class 2
Risk

About This 510(k) Submission

K133835 is an FDA 510(k) clearance for the ARTHROSURFACE KISSLOC KNOTLESS SUTURE SYSTEM, a Washer, Bolt Nut (Class II — Special Controls, product code HTN), submitted by Arthrosurface, Inc. (Franklin, US). The FDA issued a Cleared decision on July 3, 2014, 197 days after receiving the submission on December 18, 2013. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K133835 FDA.gov
FDA Decision Cleared SESE
Date Received December 18, 2013
Decision Date July 03, 2014
Days to Decision 197 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HTN — Washer, Bolt Nut
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3030