Cleared Traditional

C-Stem AMT LE Prosthesis

K220216 · Depuy Ireland UC · Orthopedic
Jul 2022
Decision
177d
Days
Class 2
Risk

About This 510(k) Submission

K220216 is an FDA 510(k) clearance for the C-Stem AMT LE Prosthesis, a Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (Class II — Special Controls, product code JDI), submitted by Depuy Ireland UC (Cork, IE). The FDA issued a Cleared decision on July 22, 2022, 177 days after receiving the submission on January 26, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3350.

Submission Details

510(k) Number K220216 FDA.gov
FDA Decision Cleared SESE
Date Received January 26, 2022
Decision Date July 22, 2022
Days to Decision 177 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code JDI — Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3350

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