Cleared Special

MINI RAIL EXTERNAL FIXATOR SYSTEM

K093550 · Small Bone Innovations, Inc. · Orthopedic

Jan 2010

Decision

51d

Days

Class 2

Risk

About This 510(k) Submission

K093550 is an FDA 510(k) clearance for the MINI RAIL EXTERNAL FIXATOR SYSTEM, a Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (Class II — Special Controls, product code KTT), submitted by Small Bone Innovations, Inc. (Morrisville, US). The FDA issued a Cleared decision on January 7, 2010, 51 days after receiving the submission on November 17, 2009. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number	K093550 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 17, 2009
Decision Date	January 07, 2010
Days to Decision	51 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	KTT — Appliance, Fixation, Nail/blade/plate Combination, Multiple Component
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3030