Cleared Traditional

ARC-2F ACETABULAR CUP

K893785 · Protek, Inc. · Orthopedic

Aug 1989

Decision

79d

Days

Class 2

Risk

About This 510(k) Submission

K893785 is an FDA 510(k) clearance for the ARC-2F ACETABULAR CUP, 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 August 9, 1989, 79 days after receiving the submission on May 22, 1989. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3360.

Submission Details

510(k) Number	K893785 FDA.gov
FDA Decision	Cleared SN
Date Received	May 22, 1989
Decision Date	August 09, 1989
Days to Decision	79 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