Cleared Traditional

Global Modular Replacement System

K233261 · Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics · Orthopedic
Dec 2023
Decision
70d
Days
Class 2
Risk

About This 510(k) Submission

K233261 is an FDA 510(k) clearance for the Global Modular Replacement System, a Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (Class II — Special Controls, product code JDI), submitted by Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics (Malwah, US). The FDA issued a Cleared decision on December 8, 2023, 70 days after receiving the submission on September 29, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3350.

Submission Details

510(k) Number K233261 FDA.gov
FDA Decision Cleared SESE
Date Received September 29, 2023
Decision Date December 08, 2023
Days to Decision 70 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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