Cleared Traditional

LARS AC Band Device

K190143 · Corin USA · Orthopedic
Nov 2019
Decision
279d
Days
Class 2
Risk

About This 510(k) Submission

K190143 is an FDA 510(k) clearance for the LARS AC Band Device, a Washer, Bolt Nut (Class II — Special Controls, product code HTN), submitted by Corin USA (Tampa, US). The FDA issued a Cleared decision on November 4, 2019, 279 days after receiving the submission on January 29, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K190143 FDA.gov
FDA Decision Cleared SESE
Date Received January 29, 2019
Decision Date November 04, 2019
Days to Decision 279 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