Cleared Traditional

RETROGRADE ROD SYSTEM

K982602 · Howmedica Corp. · Orthopedic
Sep 1998
Decision
49d
Days
Class 2
Risk

About This 510(k) Submission

K982602 is an FDA 510(k) clearance for the RETROGRADE ROD SYSTEM, a Rod, Fixation, Intramedullary And Accessories (Class II — Special Controls, product code HSB), submitted by Howmedica Corp. (Rutherford, US). The FDA issued a Cleared decision on September 14, 1998, 49 days after receiving the submission on July 27, 1998. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3020.

Submission Details

510(k) Number K982602 FDA.gov
FDA Decision Cleared SESE
Date Received July 27, 1998
Decision Date September 14, 1998
Days to Decision 49 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HSB — Rod, Fixation, Intramedullary And Accessories
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3020

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