Cleared Traditional

Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads

K173499 · Stryker Orthopaedics · Orthopedic
Mar 2018
Decision
126d
Days
Class 2
Risk

About This 510(k) Submission

K173499 is an FDA 510(k) clearance for the Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads, a Prosthesis, Hip, Femoral Component, Cemented, Metal (Class II — Special Controls, product code JDG), submitted by Stryker Orthopaedics (Malwah, US). The FDA issued a Cleared decision on March 19, 2018, 126 days after receiving the submission on November 13, 2017. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3360.

Submission Details

510(k) Number K173499 FDA.gov
FDA Decision Cleared SESE
Date Received November 13, 2017
Decision Date March 19, 2018
Days to Decision 126 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code JDG — Prosthesis, Hip, Femoral Component, Cemented, Metal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3360

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