Cleared Traditional

Exeter V40 Femoral Stem, Exeter X3 RimFit Cup

K193429 · Howmedica Osteonics Corp. · Orthopedic
Aug 2020
Decision
247d
Days
Class 2
Risk

About This 510(k) Submission

K193429 is an FDA 510(k) clearance for the Exeter V40 Femoral Stem, Exeter X3 RimFit Cup, a Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (Class II — Special Controls, product code JDI), submitted by Howmedica Osteonics Corp. (Malwah, US). The FDA issued a Cleared decision on August 13, 2020, 247 days after receiving the submission on December 10, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3350.

Submission Details

510(k) Number K193429 FDA.gov
FDA Decision Cleared SESE
Date Received December 10, 2019
Decision Date August 13, 2020
Days to Decision 247 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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