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Sources: EU EUDAMED, US FDA
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Endo TCS Driver Straight Hexalobe #6 P/N 5210-1004, Non-Sterile, Manufactured by Titan Spine, LLC. Endo TCS driver is one of the instruments within the surgical tray for use with the Interbody Fusion Device(IBD).
FDA Enforcement
Class II
·Terminated·TITAN SPINE, LLC·April 1, 2015
Endo TCS Driver Straight Hexalobe #6 P/N 5210-1004, Non-Sterile, Manufactured by Titan Spine, LLC. Endo TCS driver is one of the instruments within the surgical tray for use with the Interbody Fusion Device(IBD).
FDA Recall
Terminated
·TITAN SPINE, LLC·Product code OVE·February 20, 2015
Titan Spine Endoskeleton TA Implant products. 2107-0118 18mm Standard Endoskeleton Implant VBR 2107-0120 20mm Standard Endoskeleton Implant VBR 2107-0218 18mm Large Endoskeleton Implant VBR 2107-0220 20mm Large Endoskeleton Implant VBR Endoskeleton TA VBR is intended for use in the thoracolumbar spine (T1-L5) to replace all or part of a collapsed, damaged, or unstable vertebral body due to tumor or trauma.
FDA Enforcement
Class II
·Terminated·TITAN SPINE, LLC·December 26, 2012
Titan Spine Endoskeleton TA Implant products. 2107-0118 18mm Standard Endoskeleton Implant VBR 2107-0120 20mm Standard Endoskeleton Implant VBR 2107-0218 18mm Large Endoskeleton Implant VBR 2107-0220 20mm Large Endoskeleton Implant VBR Endoskeleton TA VBR is intended for use in the thoracolumbar spine (T1-L5) to replace all or part of a collapsed, damaged, or unstable vertebral body due to tumor or trauma.
FDA Recall
Terminated
·TITAN SPINE, LLC·Product code MQP·October 19, 2012
Endoskeleton TC
FDA UDI
TITAN SPINE, LLC·M68251801612S0·Interbody Fusion Device Parallel Large 12mm
Endoskeleton TO
FDA UDI
TITAN SPINE, LLC·M682311022100·Interbody Fusion Device 0 Degree Convex PLIF 10mm
Endoskeleton TL
FDA UDI
TITAN SPINE, LLC·M68271072111N0·Interbody Fusion Device nanoLOCK Surface Techno...
Endoskeleton TL
FDA UDI
TITAN SPINE, LLC·M68271071513N0·Interbody Fusion Device nanoLOCK Surface Techno...
ENDOSKELETON® TL
FDA UDI
TITAN SPINE, LLC·00191375006015·Interbody Fusion Device Parallel 50 (M/L) 26 (A...
ENDOSKELETON TC
FDA UDI
TITAN SPINE, LLC·M682526014070·PARALLEL, TRIAL, MEDIUM, 7MM
Endoskeleton TL
FDA UDI
TITAN SPINE, LLC·M682711203110·Interbody Fusion Device 12 Degree 50 (M/L) 18 (...
ENDOSKELETON® TL Hyperlordotic
FDA UDI
TITAN SPINE, LLC·00191375042310·20 Deg Lordotic Trial, 15mm x 18mm
ENDOSKELETON® TL
FDA UDI
TITAN SPINE, LLC·00191375043201·Box Chisel, Straight, 22mm x 9mm
Endoskeleton TL
FDA UDI
TITAN SPINE, LLC·M682710003140·Interbody Fusion Device Parallel 50 (M/L) 18 (A...
Endoskeleton TT
FDA UDI
TITAN SPINE, LLC·M682411035080·Interbody Fusion Device Parallel X-Large 8mm
Endoskeleton TL
FDA UDI
TITAN SPINE, LLC·M68271072514S0·Interbody Fusion Device 7 Degree 60 (M/L) 26 (...
Endoskeleton TL
FDA UDI
TITAN SPINE, LLC·M682710724090·Interbody Fusion Device 7 Degree 55 (M/L) 26 (A...
Endoskeleton TL
FDA UDI
TITAN SPINE, LLC·M682710013090·Interbody Fusion Device Parallel 50 (M/L) 22 (A...
ENDOSKELETON® TL Sterile Barrier System
FDA UDI
TITAN SPINE, LLC·00191375022985·Interbody Fusion Device 7 Degree 45 (M/L) 22 (...
ENDOSKELETON® TL Hyperlordotic nanoLOCK® Surface Technology
FDA UDI
TITAN SPINE, LLC·00191375037552·Interbody Fusion Device 30 Degree 40 (M/L) 18 (...