Cleared Traditional

TEZO TITANIUM CAGE FAMILY

K122957 · Ulrich GmbH & Co. KG · Orthopedic

Jun 2013

Decision

269d

Days

Class 2

Risk

About This 510(k) Submission

K122957 is an FDA 510(k) clearance for the TEZO TITANIUM CAGE FAMILY, 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 June 21, 2013, 269 days after receiving the submission on September 25, 2012. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K122957 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 25, 2012
Decision Date	June 21, 2013
Days to Decision	269 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.