Cleared Traditional

K131647 - TRINITY ACETABULAR SYSTEM
(FDA 510(k) Clearance)

K131647 · Corin USA · Orthopedic

Sep 2013

Decision

114d

Days

Class 2

Risk

K131647 is an FDA 510(k) clearance for the TRINITY ACETABULAR SYSTEM. This device is classified as 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 27, 2013, 114 days after receiving the submission on June 5, 2013.

This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3353.

Submission Details

510(k) Number	K131647 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 05, 2013
Decision Date	September 27, 2013
Days to Decision	114 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