Cleared Traditional

FEMORAL HEADS/MODULAR & FIXED W/ TITAN NITRIDE SUR

K892059 · Protek, Inc. · Orthopedic
Jul 1989
Decision
112d
Days
Class 2
Risk

About This 510(k) Submission

K892059 is an FDA 510(k) clearance for the FEMORAL HEADS/MODULAR & FIXED W/ TITAN NITRIDE SUR, a Prosthesis, Hip, Hemi-, Femoral, Metal Ball (Class II — Special Controls, product code LZY), submitted by Protek, Inc. (Indianapolis, US). The FDA issued a Cleared decision on July 19, 1989, 112 days after receiving the submission on March 29, 1989. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3360.

Submission Details

510(k) Number K892059 FDA.gov
FDA Decision Cleared SESE
Date Received March 29, 1989
Decision Date July 19, 1989
Days to Decision 112 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary —

Device Classification

Product Code LZY — Prosthesis, Hip, Hemi-, Femoral, Metal Ball
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3360