Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody Fusion Device And Endoskeleton® TCS Interbody Fusion Device

Intervertebral Fusion Device With Bone Graft, Cervical

Titan Spine, LLC

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

Pre-market Notification Details

• Device ID: K173535
• 510k Number: K173535
• Device Name: Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody Fusion Device And Endoskeleton® TCS Interbody Fusion Device
• Classification: Intervertebral Fusion Device With Bone Graft, Cervical
• Applicant: Titan Spine, LLC 6140 W. Executive Dr., Suite A Mequon, WI 53092
• Contact: Jane Rodd
• Correspondent: Christine Scifert; MRC/X, LLC 6075 Poplar Ave. Memphis, TN 38119
• Product Code: ODP
• Subsequent Product Code: OVD
• Subsequent Product Code: OVE
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-11-15
• Decision Date: 2018-02-13
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00191375029076	K173535	000
00191375027614	K173535	000
00191375027591	K173535	000
00191375027553	K173535	000
00191375027539	K173535	000
00191375027515	K173535	000
00191375027508	K173535	000
00191375027478	K173535	000
00191375027454	K173535	000
00191375027430	K173535	000
00191375027638	K173535	000
00191375027669	K173535	000
00191375027676	K173535	000
00191375029069	K173535	000
00191375027379	K173535	000
00191375027355	K173535	000
00191375027348	K173535	000
00191375026327	K173535	000
00191375027713	K173535	000
00191375027706	K173535	000
00191375027690	K173535	000
00191375027683	K173535	000
00191375027393	K173535	000