Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TO Interbody Fusion Device, Endoskeleton® TT Interbody Fusion Device, Endoskeleton® TC Interbody Fusion Device, Endoskeleton® TCS Interbody Fusion Devi

Intervertebral Fusion Device With Bone Graft, Cervical

Titan Spine, Inc

The following data is part of a premarket notification filed by Titan Spine, Inc with the FDA for Endoskeleton® Ta Interbody Fusion Device, Endoskeleton® Tas Interbody Fusion Device, Endoskeleton® To Interbody Fusion Device, Endoskeleton® Tt Interbody Fusion Device, Endoskeleton® Tc Interbody Fusion Device, Endoskeleton® Tcs Interbody Fusion Devi.

Pre-market Notification Details

• Device ID: K183557
• 510k Number: K183557
• Device Name: Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TO Interbody Fusion Device, Endoskeleton® TT Interbody Fusion Device, Endoskeleton® TC Interbody Fusion Device, Endoskeleton® TCS Interbody Fusion Devi
• Classification: Intervertebral Fusion Device With Bone Graft, Cervical
• Applicant: Titan Spine, Inc 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: MAX
• Subsequent Product Code: MQP
• 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: 2018-12-20
• Decision Date: 2019-02-11
• Summary: summary