Cleared Traditional

NOVEL TAPERED HIP STEM

K103479 · Stryker Corp. · Orthopedic

Mar 2011

Decision

104d

Days

Class 2

Risk

About This 510(k) Submission

K103479 is an FDA 510(k) clearance for the NOVEL TAPERED HIP STEM, a Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate (Class II — Special Controls, product code MEH), submitted by Stryker Corp. (Malwah, US). The FDA issued a Cleared decision on March 10, 2011, 104 days after receiving the submission on November 26, 2010. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3353.

Submission Details

510(k) Number	K103479 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 26, 2010
Decision Date	March 10, 2011
Days to Decision	104 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	MEH — Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3353