Cleared Traditional

HOWMEDICA TITANIUM HOFFMANN FIXATION PIN SYSTEM

K982068 · Howmedica Corp. · Orthopedic
Aug 1998
Decision
80d
Days
Class 2
Risk

About This 510(k) Submission

K982068 is an FDA 510(k) clearance for the HOWMEDICA TITANIUM HOFFMANN FIXATION PIN SYSTEM, a Pin, Fixation, Threaded (Class II — Special Controls, product code JDW), submitted by Howmedica Corp. (Rutherford, US). The FDA issued a Cleared decision on August 31, 1998, 80 days after receiving the submission on June 12, 1998. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K982068 FDA.gov
FDA Decision Cleared SESE
Date Received June 12, 1998
Decision Date August 31, 1998
Days to Decision 80 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code JDW — Pin, Fixation, Threaded
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3040

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