Cleared Traditional

K853768 - MULLER SELF LOCKING TOTAL HIP
(FDA 510(k) Clearance)

K853768 · Protek, Inc. · Orthopedic
Nov 1985
Decision
71d
Days
Class 2
Risk

K853768 is an FDA 510(k) clearance for the MULLER SELF LOCKING TOTAL HIP. This device is classified as a Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (Class II — Special Controls, product code JDI).

Submitted by Protek, Inc. (Indianapolis, US). The FDA issued a Cleared decision on November 19, 1985, 71 days after receiving the submission on September 9, 1985.

This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3350.

Submission Details

510(k) Number K853768 FDA.gov
FDA Decision Cleared SESE
Date Received September 09, 1985
Decision Date November 19, 1985
Days to Decision 71 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary —

Device Classification

Product Code JDI — Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3350

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