Endoskeleton TCS Interbody Fusion Device

Intervertebral Fusion Device With Integrated Fixation, Cervical

TITAN SPINE, LLC

The following data is part of a premarket notification filed by Titan Spine, Llc with the FDA for Endoskeleton Tcs Interbody Fusion Device.

Pre-market Notification Details

• Device ID: K151596
• 510k Number: K151596
• Device Name: Endoskeleton TCS Interbody Fusion Device
• Classification: Intervertebral Fusion Device With Integrated Fixation, Cervical
• Applicant: TITAN SPINE, LLC 6140 W. EXECUTIVE DRIVE, SUITE A Mequon, WI 53092
• Contact: Jane Rodd
• Correspondent: Christine Scifert; MEMPHIS REGULATORY CONSULTING, LLC 3416 ROXEE RUN COVE Bartlett, TN 38133
• Product Code: OVE
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-06-12
• Decision Date: 2015-10-09
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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