Cleared Traditional

SCHUSTER ACETABULAR CUP FOR CEMENT/CEMENTLESS FIX.

K870923 · Protek, Inc. · Orthopedic

Sep 1987

Decision

194d

Days

Class 3

Risk

About This 510(k) Submission

K870923 is an FDA 510(k) clearance for the SCHUSTER ACETABULAR CUP FOR CEMENT/CEMENTLESS FIX., a Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component) (Class III — Premarket Approval, product code KWA), submitted by Protek, Inc. (Indianapolis, US). The FDA issued a Cleared decision on September 14, 1987, 194 days after receiving the submission on March 4, 1987. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3330.

Submission Details

510(k) Number	K870923 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 04, 1987
Decision Date	September 14, 1987
Days to Decision	194 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	—

Device Classification

Product Code	KWA — Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component)
Device Class	Class III — Premarket Approval
CFR Regulation	21 CFR 888.3330