Cleared Traditional

OVATION 10/12 HIP STEM

K131022 · Ortho Development Corp. · Orthopedic

Oct 2013

Decision

187d

Days

Class 2

Risk

About This 510(k) Submission

K131022 is an FDA 510(k) clearance for the OVATION 10/12 HIP STEM, a Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (Class II — Special Controls, product code LPH), submitted by Ortho Development Corp. (Draper, US). The FDA issued a Cleared decision on October 16, 2013, 187 days after receiving the submission on April 12, 2013. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3358.

Submission Details

510(k) Number	K131022 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 12, 2013
Decision Date	October 16, 2013
Days to Decision	187 days
Submission Type	Traditional
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