Cleared Traditional

ACETABULAR SHELLS WITH MESH INGROWTH SURFACE

K973163 · Howmedica Corp. · Orthopedic

Nov 1997

Decision

88d

Days

Class 2

Risk

About This 510(k) Submission

K973163 is an FDA 510(k) clearance for the ACETABULAR SHELLS WITH MESH INGROWTH SURFACE, a Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (Class II — Special Controls, product code LPH), submitted by Howmedica Corp. (Rutherford, US). The FDA issued a Cleared decision on November 21, 1997, 88 days after receiving the submission on August 25, 1997. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3358.

Submission Details

510(k) Number	K973163 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 25, 1997
Decision Date	November 21, 1997
Days to Decision	88 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	LPH — Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3358