Cleared Traditional

VARIOUS FEMORAL HIP PROSTHESES W/SELF LOCK CERAMIC

K884952 · Protek, Inc. · Orthopedic

May 1989

Decision

162d

Days

Class 2

Risk

About This 510(k) Submission

K884952 is an FDA 510(k) clearance for the VARIOUS FEMORAL HIP PROSTHESES W/SELF LOCK CERAMIC, a Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (Class II — Special Controls, product code LZO), submitted by Protek, Inc. (Indianapolis, US). The FDA issued a Cleared decision on May 10, 1989, 162 days after receiving the submission on November 29, 1988. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3353.

Submission Details

510(k) Number	K884952 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 29, 1988
Decision Date	May 10, 1989
Days to Decision	162 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	—

Device Classification

Product Code	LZO — Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3353