Cleared Traditional

EXETER X3 RIMFIT ACETABULAR CUP

K111848 · Stryker Corp. · Orthopedic
Oct 2011
Decision
98d
Days
Class 2
Risk

About This 510(k) Submission

K111848 is an FDA 510(k) clearance for the EXETER X3 RIMFIT ACETABULAR CUP, a Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (Class II — Special Controls, product code JDI), submitted by Stryker Corp. (Malwah, US). The FDA issued a Cleared decision on October 5, 2011, 98 days after receiving the submission on June 29, 2011. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3350.

Submission Details

510(k) Number K111848 FDA.gov
FDA Decision Cleared SESE
Date Received June 29, 2011
Decision Date October 05, 2011
Days to Decision 98 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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