Cleared Traditional

Corin Optimized Positioning System (OPS) Femoral

K193545 · Corin USA · Orthopedic

Aug 2020

Decision

228d

Days

Class 2

Risk

About This 510(k) Submission

K193545 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 August 4, 2020, 228 days after receiving the submission on December 20, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3353.

Submission Details

510(k) Number	K193545 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 20, 2019
Decision Date	August 04, 2020
Days to Decision	228 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