Cleared Traditional

THE LEIBINGER ADVANCE INTERNAL MIDFACE DISTRACTION SYSTEM

K092743 · Stryker Craniomaxillofacial · Dental

Jan 2010

Decision

129d

Days

Class 2

Risk

About This 510(k) Submission

K092743 is an FDA 510(k) clearance for the THE LEIBINGER ADVANCE INTERNAL MIDFACE DISTRACTION SYSTEM, a Plate, Bone (Class II — Special Controls, product code JEY), submitted by Stryker Craniomaxillofacial (Kalamazoo, US). The FDA issued a Cleared decision on January 15, 2010, 129 days after receiving the submission on September 8, 2009. This device falls under the Dental review panel. Regulated under 21 CFR 872.4760.

Submission Details

510(k) Number	K092743 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 08, 2009
Decision Date	January 15, 2010
Days to Decision	129 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF