Cleared Traditional

ENCOMPASS CEMENTED HIP STEM & 10/12 COBALT-CHROME FEMORAL HEADS

K050637 · Ortho Development Corp. · Orthopedic
Sep 2005
Decision
196d
Days
Class 2
Risk

About This 510(k) Submission

K050637 is an FDA 510(k) clearance for the ENCOMPASS CEMENTED HIP STEM & 10/12 COBALT-CHROME FEMORAL HEADS, a Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (Class II — Special Controls, product code JDI), submitted by Ortho Development Corp. (Draper, US). The FDA issued a Cleared decision on September 23, 2005, 196 days after receiving the submission on March 11, 2005. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3350.

Submission Details

510(k) Number K050637 FDA.gov
FDA Decision Cleared SESE
Date Received March 11, 2005
Decision Date September 23, 2005
Days to Decision 196 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement

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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