Cleared Traditional

TYPE 3 FEMORAL COMPONENTS

K983404 · Howmedica Corp. · Orthopedic

Dec 1998

Decision

85d

Days

Class 2

Risk

About This 510(k) Submission

K983404 is an FDA 510(k) clearance for the TYPE 3 FEMORAL COMPONENTS, a Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (Class II — Special Controls, product code LZO), submitted by Howmedica Corp. (Rutherford, US). The FDA issued a Cleared decision on December 22, 1998, 85 days after receiving the submission on September 28, 1998. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3353.

Submission Details

510(k) Number	K983404 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 28, 1998
Decision Date	December 22, 1998
Days to Decision	85 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	LZO — Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3353