Cleared Special

Legend Acetabular Liners

K173951 · Ortho Development Corporation · Orthopedic

May 2018

Decision

154d

Days

Class 2

Risk

About This 510(k) Submission

K173951 is an FDA 510(k) clearance for the Legend Acetabular Liners, a Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (Class II — Special Controls, product code LPH), submitted by Ortho Development Corporation (Draper, US). The FDA issued a Cleared decision on May 30, 2018, 154 days after receiving the submission on December 27, 2017. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3358.

Submission Details

510(k) Number	K173951 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 27, 2017
Decision Date	May 30, 2018
Days to Decision	154 days
Submission Type	Special
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