Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion Device
Titan Spine, Inc
TITAN SPINE, INC
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3006340236 | 3006340236 | TITAN SPINE, INC | 1 | N | 2020-04-25 | 6140 W. EXECUTIVE DR SUITE A MEQUON WI US 53092 |
| 3014282727 | 3014282727 | Titan Spine, INC | 1 | N | 2020-04-25 | 4006 Willow Lake Blvd MPHS TN US 38118 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 216295 | 1511019178 | K901035 | FIBER OPTIC LIGHT GUIDE OR FIBER OPTIC CABLE | FST | 1990-04-23 |
| 68116 | 1085964984 | K192054 | Endoskeleton TAS Plate | OVD | 2019-08-29 |
| 216295 | 1085964984 | K192054 | Endoskeleton TAS Plate | OVD | 2019-08-29 |
| 216295 | 1894316569 | K191581 | Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion Device | OVD | 2020-01-08 |
| 68116 | 1894316569 | K191581 | Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion Device | OVD | 2020-01-08 |
| 68116 | 1043235009 | K191565 | Endoskeleton TCS Interbody Fusion Device | OVE | 2019-08-06 |
| 216295 | 1043235009 | K191565 | Endoskeleton TCS Interbody Fusion Device | OVE | 2019-08-06 |
| 68116 | 1856192269 | K173535 | Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody Fusion Device and Endoskeleton® TCS Interbody Fusion Device | ODP | 2018-02-13 |
| 216295 | 1856192269 | K173535 | Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody Fusion Device and Endoskeleton® TCS Interbody Fusion Device | ODP | 2018-02-13 |
| 68116 | 1532871330 | K163269 | Endoskeleton(R) TAS Interbody Fusion Device / Endoskeleton(R) TAS Hyperlordotic Interbody Fusion Device | OVD | 2017-04-13 |
| 216295 | 1532871330 | K163269 | Endoskeleton(R) TAS Interbody Fusion Device / Endoskeleton(R) TAS Hyperlordotic Interbody Fusion Device | OVD | 2017-04-13 |
| 68116 | 1097715663 | K153122 | Endoskeleton(r) TCS System | OVE | 2015-12-14 |
| 216295 | 1097715663 | K153122 | Endoskeleton(r) TCS System | OVE | 2015-12-14 |
| 68116 | 1615949211 | K151596 | Endoskeleton TCS Interbody Fusion Device | OVE | 2015-10-09 |
| 216295 | 1615949211 | K151596 | Endoskeleton TCS Interbody Fusion Device | OVE | 2015-10-09 |
| 216295 | 1867141710 | K142940 | Endoskeleton TCS System | OVE | 2015-01-28 |
| 68116 | 1867141710 | K142940 | Endoskeleton TCS System | OVE | 2015-01-28 |
| 68116 | 1993981899 | K142589 | Endoskeleton TA IBD and VBR, Endoskeleton TO and TT, Endoskeleton TAS, Endoskeleton TAS, Endoskeleton TC, Endoskeleton TL | MAX | 2014-10-17 |
| 216295 | 1993981899 | K142589 | Endoskeleton TA IBD and VBR, Endoskeleton TO and TT, Endoskeleton TAS, Endoskeleton TAS, Endoskeleton TC, Endoskeleton TL | MAX | 2014-10-17 |
| 68116 | 2067004005 | K141953 | ENDOSKELETON; TA IBD AND VBR, TO AND TT, TAS, TC, TL | MAX | 2014-10-27 |
| 216295 | 2067004005 | K141953 | ENDOSKELETON; TA IBD AND VBR, TO AND TT, TAS, TC, TL | MAX | 2014-10-27 |
| 68116 | 1681490701 | K140055 | ENDOSKELETON(R) TL INTERBODY FUSION DEVICE | MAX | 2014-07-02 |
| 216295 | 1681490701 | K140055 | ENDOSKELETON(R) TL INTERBODY FUSION DEVICE | MAX | 2014-07-02 |
| 68116 | 1394687755 | K111626 | ENDOSKELETON(R) TAS | OVD | 2011-09-09 |
| 216295 | 1394687755 | K111626 | ENDOSKELETON(R) TAS | OVD | 2011-09-09 |
| 68116 | 1643822827 | K102067 | ENDOSKELETON TO | MAX | 2010-11-05 |
| 216295 | 1643822827 | K102067 | ENDOSKELETON TO | MAX | 2010-11-05 |
| 68116 | 1431385276 | K100889 | ENDOSKELETON TC | ODP | 2010-07-29 |
| 216295 | 1431385276 | K100889 | ENDOSKELETON TC | ODP | 2010-07-29 |
| 68116 | 1065589739 | K083714 | ENDOSKELETON TT INTERBODY FUSION DEVICE (IBD) | MAX | 2009-04-15 |
| 216295 | 1065589739 | K083714 | ENDOSKELETON TT INTERBODY FUSION DEVICE (IBD) | MAX | 2009-04-15 |
| 68116 | 1783470684 | K080615 | ENDOSKELETON TA INTERBODY FUSION DEVICE (IBD) | MAX | 2008-06-17 |
| 216295 | 1783470684 | K080615 | ENDOSKELETON TA INTERBODY FUSION DEVICE (IBD) | MAX | 2008-06-17 |
| 216295 | 1342398284 | K063729 | DISPOSABLE PEDICLE SCREW PROBE, MODEL 3603-00 | GXZ | 2007-08-21 |
| 68116 | 1376109617 | K032812 | ENDOSKELETON TA VERTEBRAL BODY REPLACEMENT | MQP | 2003-12-08 |
| 216295 | 1376109617 | K032812 | ENDOSKELETON TA VERTEBRAL BODY REPLACEMENT | MQP | 2003-12-08 |
| 68116 | 1188768894 | ||||
| 216295 | 1188768894 | ||||
| 216295 | 1248916068 | ||||
| 68116 | 1282709390 | ||||
| 216295 | 1282709390 | ||||
| 68116 | 1292445032 | ||||
| 216295 | 1292445032 | ||||
| 216295 | 1308820063 | ||||
| 68116 | 1308820063 | ||||
| 68116 | 1393042257 | ||||
| 216295 | 1393042257 | ||||
| 68116 | 1409050004 | ||||
| 216295 | 1409050004 | ||||
| 68116 | 1525628760 | ||||
| 216295 | 1525628760 | ||||
| 68116 | 1735728633 | ||||
| 216295 | 1735728633 | ||||
| 68116 | 1934705664 | ||||
| 68116 | 1994679059 | ||||
| 216295 | 1994679059 | ||||
| 68116 | 2034527433 | ||||
| 216295 | 2034527433 |
Product Codes Associated With Registrations#
PMN#
Endoskeleton TAS Plate
Titan Spine, Inc
Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS And TAS Hyperlordotic Interbody Fusion Device, Endoskeleton TO Interbody Fusion Device, Endoskeleton TT Interbody Fusion Device, Endoskeleton TC Interbody Fusion Device, Endoskeleton TCS Inter
Titan Spine, Inc
Endoskeleton TCS Interbody Fusion Device
Titan Spine, Inc
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
Titan Spine, Inc