Cleared Traditional

SYNTHES DISTRACTION OSTEOGENESIS SYSTEM, MR CONDITIONAL WITH EXPANDED INDICATIONS

K092190 · Synthes (Usa) · Orthopedic

May 2010

Decision

294d

Days

Class 2

Risk

About This 510(k) Submission

K092190 is an FDA 510(k) clearance for the SYNTHES DISTRACTION OSTEOGENESIS SYSTEM, MR CONDITIONAL WITH EXPANDED INDICATIONS, a Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (Class II — Special Controls, product code KTT), submitted by Synthes (Usa) (19380, US). The FDA issued a Cleared decision on May 11, 2010, 294 days after receiving the submission on July 21, 2009. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number	K092190 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 21, 2009
Decision Date	May 11, 2010
Days to Decision	294 days
Submission Type	Traditional
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