Cleared Special

K053528 - SHORT CITATION FEMORAL STEM
(FDA 510(k) Clearance)

K053528 · Stryker Orthopaedics · Orthopedic

Jan 2006

Decision

25d

Days

Class 2

Risk

K053528 is an FDA 510(k) clearance for the SHORT CITATION FEMORAL STEM, a Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate (Class II — Special Controls, product code MEH), submitted by Stryker Orthopaedics (Malwah, US). The FDA issued a Cleared decision on January 13, 2006, 25 days after receiving the submission on December 19, 2005. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3353.

Submission Details

510(k) Number	K053528 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 19, 2005
Decision Date	January 13, 2006
Days to Decision	25 days
Submission Type	Special
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