Cleared Traditional

Corin Optimized Positioning System (OPS) Femoral

K181061 · Corin USA · Orthopedic

Sep 2018

Decision

137d

Days

Class 2

Risk

About This 510(k) Submission

K181061 is an FDA 510(k) clearance for the Corin Optimized Positioning System (OPS) Femoral, a Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (Class II — Special Controls, product code LZO), submitted by Corin USA (Tampa, US). The FDA issued a Cleared decision on September 7, 2018, 137 days after receiving the submission on April 23, 2018. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3353.

Submission Details

510(k) Number	K181061 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 23, 2018
Decision Date	September 07, 2018
Days to Decision	137 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	LZO — Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3353