Cleared Traditional

KISSloc Suture System

K170440 · Arthrosurface, Inc. · Orthopedic
May 2017
Decision
78d
Days
Class 2
Risk

About This 510(k) Submission

K170440 is an FDA 510(k) clearance for the KISSloc 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 May 3, 2017, 78 days after receiving the submission on February 14, 2017. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K170440 FDA.gov
FDA Decision Cleared SESE
Date Received February 14, 2017
Decision Date May 03, 2017
Days to Decision 78 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