Cleared Traditional

P.S.A. FEMORAL HIP PROSTHESIS

K893959 · Protek, Inc. · Orthopedic

Jul 1989

Decision

54d

Days

Class 2

Risk

About This 510(k) Submission

K893959 is an FDA 510(k) clearance for the P.S.A. FEMORAL HIP PROSTHESIS, a Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented (Class II — Special Controls, product code KWY), submitted by Protek, Inc. (Indianapolis, US). The FDA issued a Cleared decision on July 25, 1989, 54 days after receiving the submission on June 1, 1989. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3390.

Submission Details

510(k) Number	K893959 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 01, 1989
Decision Date	July 25, 1989
Days to Decision	54 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	—

Device Classification

Product Code	KWY — Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3390