Cleared Traditional

EXETER Centralizer, EXETER 2.5mm Plug

K191414 · Stryker Orthopaedics · Orthopedic
Aug 2019
Decision
92d
Days
Class 2
Risk

About This 510(k) Submission

K191414 is an FDA 510(k) clearance for the EXETER Centralizer, EXETER 2.5mm Plug, a Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (Class II — Special Controls, product code JDI), submitted by Stryker Orthopaedics (Malwah, US). The FDA issued a Cleared decision on August 28, 2019, 92 days after receiving the submission on May 28, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3350.

Submission Details

510(k) Number K191414 FDA.gov
FDA Decision Cleared SESE
Date Received May 28, 2019
Decision Date August 28, 2019
Days to Decision 92 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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