Cleared Traditional

RESUBMITTED CLW ACETABULAR CUP W/SULMESH

K883794 · Protek, Inc. · Orthopedic

May 1989

Decision

261d

Days

Class 2

Risk

About This 510(k) Submission

K883794 is an FDA 510(k) clearance for the RESUBMITTED CLW ACETABULAR CUP W/SULMESH, a Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented (Class II — Special Controls, product code LWJ), submitted by Protek, Inc. (Indianapolis, US). The FDA issued a Cleared decision on May 26, 1989, 261 days after receiving the submission on September 7, 1988. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3360.

Submission Details

510(k) Number	K883794 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 07, 1988
Decision Date	May 26, 1989
Days to Decision	261 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	—

Device Classification

Product Code	LWJ — Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3360