Cleared Traditional

DURATION II ACETABULAR COMPONENTS-ETHYLENE OXIDE STERILIZATION

K980926 · Howmedica Corp. · Orthopedic
Dec 1998
Decision
280d
Days
Class 2
Risk

About This 510(k) Submission

K980926 is an FDA 510(k) clearance for the DURATION II ACETABULAR COMPONENTS-ETHYLENE OXIDE STERILIZATION, a Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (Class II — Special Controls, product code JDI), submitted by Howmedica Corp. (Rutherford, US). The FDA issued a Cleared decision on December 16, 1998, 280 days after receiving the submission on March 11, 1998. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3350.

Submission Details

510(k) Number K980926 FDA.gov
FDA Decision Cleared SESE
Date Received March 11, 1998
Decision Date December 16, 1998
Days to Decision 280 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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