Cleared Traditional

Corin Optimized Position System Functional Hip Analysis (OPS FHA)

K190834 · Corin USA · Orthopedic

Jul 2019

Decision

112d

Days

Class 2

Risk

About This 510(k) Submission

K190834 is an FDA 510(k) clearance for the Corin Optimized Position System Functional Hip Analysis (OPS FHA), 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 July 22, 2019, 112 days after receiving the submission on April 1, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3353.

Submission Details

510(k) Number	K190834 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 01, 2019
Decision Date	July 22, 2019
Days to Decision	112 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