Cleared Traditional

MUELLER CURVED STEM HEMI-PROSTHESIS

K853662 · Protek, Inc. · Orthopedic
Sep 1985
Decision
21d
Days
Class 2
Risk

About This 510(k) Submission

K853662 is an FDA 510(k) clearance for the MUELLER CURVED STEM HEMI-PROSTHESIS, a Prosthesis, Hip, Hemi-, Femoral, Metal (Class II — Special Controls, product code KWL), submitted by Protek, Inc. (Indianapolis, US). The FDA issued a Cleared decision on September 24, 1985, 21 days after receiving the submission on September 3, 1985. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3360.

Submission Details

510(k) Number K853662 FDA.gov
FDA Decision Cleared SESE
Date Received September 03, 1985
Decision Date September 24, 1985
Days to Decision 21 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary —

Device Classification

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

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