Cleared Traditional

Alpine Cemented Hip System

K153216 · Ortho Development Corporation · Orthopedic
Feb 2016
Decision
105d
Days
Class 2
Risk

About This 510(k) Submission

K153216 is an FDA 510(k) clearance for the Alpine Cemented Hip System, a Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (Class II — Special Controls, product code JDI), submitted by Ortho Development Corporation (Draper, US). The FDA issued a Cleared decision on February 18, 2016, 105 days after receiving the submission on November 5, 2015. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3350.

Submission Details

510(k) Number K153216 FDA.gov
FDA Decision Cleared SESE
Date Received November 05, 2015
Decision Date February 18, 2016
Days to Decision 105 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

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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