Cleared Traditional

PARTNERSHIP REVISION FEMORAL STEMS

K972893 · Howmedica Corp. · Orthopedic

Nov 1997

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K972893 is an FDA 510(k) clearance for the PARTNERSHIP REVISION FEMORAL STEMS, 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 November 3, 1997, 90 days after receiving the submission on August 5, 1997. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3353.

Submission Details

510(k) Number	K972893 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 05, 1997
Decision Date	November 03, 1997
Days to Decision	90 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