Cleared Traditional

HOWMEDICA AND HOWMEDICA LEIBINGER BONE SCREW WASHERS

K980364 · Howmedica Corp. · Orthopedic
Apr 1998
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K980364 is an FDA 510(k) clearance for the HOWMEDICA AND HOWMEDICA LEIBINGER BONE SCREW WASHERS, a Screw, Fixation, Bone (Class II — Special Controls, product code HWC), submitted by Howmedica Corp. (Rutherford, US). The FDA issued a Cleared decision on April 29, 1998, 90 days after receiving the submission on January 29, 1998. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K980364 FDA.gov
FDA Decision Cleared SESE
Date Received January 29, 1998
Decision Date April 29, 1998
Days to Decision 90 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HWC — Screw, Fixation, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3040

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