Cleared Traditional

HOWMEDICA MODULAR REPLACEMENT SYSTEM - DISTAL FEMORAL/PROXIMAL TIBIAL SEGMENTS

K972401 · Howmedica Corp. · Orthopedic
Jul 1998
Decision
382d
Days
Class 2
Risk

About This 510(k) Submission

K972401 is an FDA 510(k) clearance for the HOWMEDICA MODULAR REPLACEMENT SYSTEM - DISTAL FEMORAL/PROXIMAL TIBIAL SEGMENTS, a Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer (Class II — Special Controls, product code KRO), submitted by Howmedica Corp. (Rutherford, US). The FDA issued a Cleared decision on July 13, 1998, 382 days after receiving the submission on June 26, 1997. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3510.

Submission Details

510(k) Number K972401 FDA.gov
FDA Decision Cleared SESE
Date Received June 26, 1997
Decision Date July 13, 1998
Days to Decision 382 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code KRO — Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3510

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