Cleared Traditional

LEGEND ALL-POLY CUP

K051407 · Ortho Development Corp. · Orthopedic
Sep 2005
Decision
100d
Days
Class 2
Risk

About This 510(k) Submission

K051407 is an FDA 510(k) clearance for the LEGEND ALL-POLY CUP, 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 8, 2005, 100 days after receiving the submission on May 31, 2005. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3350.

Submission Details

510(k) Number K051407 FDA.gov
FDA Decision Cleared SESE
Date Received May 31, 2005
Decision Date September 08, 2005
Days to Decision 100 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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