Cleared Traditional

Entrada? hip stem

K171249 · Ortho Development Corporation · Orthopedic

Aug 2017

Decision

118d

Days

Class 2

Risk

About This 510(k) Submission

K171249 is an FDA 510(k) clearance for the Entrada? hip stem, a Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate (Class II — Special Controls, product code MEH), submitted by Ortho Development Corporation (Draper, US). The FDA issued a Cleared decision on August 24, 2017, 118 days after receiving the submission on April 28, 2017. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3353.

Submission Details

510(k) Number	K171249 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 28, 2017
Decision Date	August 24, 2017
Days to Decision	118 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	MEH — Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3353