Endoskeleton TA IBD And VBR, Endoskeleton TO And TT, Endoskeleton TAS, Endoskeleton TAS, Endoskeleton TC, Endoskeleton TL

Intervertebral Fusion Device With Bone Graft, Lumbar

TITAN SPINE, LLC

The following data is part of a premarket notification filed by Titan Spine, Llc with the FDA for Endoskeleton Ta Ibd And Vbr, Endoskeleton To And Tt, Endoskeleton Tas, Endoskeleton Tas, Endoskeleton Tc, Endoskeleton Tl.

Pre-market Notification Details

• Device ID: K142589
• 510k Number: K142589
• Device Name: Endoskeleton TA IBD And VBR, Endoskeleton TO And TT, Endoskeleton TAS, Endoskeleton TAS, Endoskeleton TC, Endoskeleton TL
• Classification: Intervertebral Fusion Device With Bone Graft, Lumbar
• Applicant: TITAN SPINE, LLC 6140 WEST EXECUTIVE DRIVE, SUITE A Mequon, WI 53092
• Contact: Jane Rodd
• Correspondent: Kimberly Strohkirch; MEMPHIS REGULATORY CONSULTING, LLC 3416 ROXEE RUN COVE Bartlett, TN 38133
• Product Code: MAX
• Subsequent Product Code: MQP
• Subsequent Product Code: ODP
• Subsequent Product Code: OVD
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-09-15
• Decision Date: 2014-10-17
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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