Cleared Traditional

PEZO INTERBODY CAGES SYSTEM

K103814 · Ulrich GmbH & Co. KG · Orthopedic

Mar 2011

Decision

78d

Days

Class 2

Risk

About This 510(k) Submission

K103814 is an FDA 510(k) clearance for the PEZO INTERBODY CAGES SYSTEM, a Intervertebral Fusion Device With Bone Graft, Lumbar (Class II — Special Controls, product code MAX), submitted by Ulrich GmbH & Co. KG (Chesterfield, US). The FDA issued a Cleared decision on March 17, 2011, 78 days after receiving the submission on December 29, 2010. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K103814 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 29, 2010
Decision Date	March 17, 2011
Days to Decision	78 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	MAX — Intervertebral Fusion Device With Bone Graft, Lumbar
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3080
Definition	Intended To Stabilize Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft.