Cleared Special

K213839 - DePuy Corail AMT Hip Prosthesis
(FDA 510(k) Clearance)

K213839 · DePuy Orthopaedics, Inc. · Orthopedic

Jan 2022

Decision

28d

Days

Class 2

Risk

K213839 is an FDA 510(k) clearance for the DePuy Corail AMT Hip Prosthesis, a Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (Class II — Special Controls, product code LZO), submitted by DePuy Orthopaedics, Inc. (Warsaw, US). The FDA issued a Cleared decision on January 6, 2022, 28 days after receiving the submission on December 9, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3353.

Submission Details

510(k) Number	K213839 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 09, 2021
Decision Date	January 06, 2022
Days to Decision	28 days
Submission Type	Special
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