Cleared Traditional

ORTHOMET HMC FEMORAL STEM COMPONENT

K936310 · Orthomet, Inc. · Orthopedic

Jun 1995

Decision

426d

Days

Class 2

Risk

About This 510(k) Submission

K936310 is an FDA 510(k) clearance for the ORTHOMET HMC FEMORAL STEM COMPONENT, a Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (Class II — Special Controls, product code LPH), submitted by Orthomet, Inc. (Minneapolis, US). The FDA issued a Cleared decision on June 7, 1995, 426 days after receiving the submission on April 7, 1994. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3358.

Submission Details

510(k) Number	K936310 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 07, 1994
Decision Date	June 07, 1995
Days to Decision	426 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	LPH — Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3358