Titan Spine, LLC

• MAX — Orthopedic7 devices
• OVE — Orthopedic3 devices
• ODP — Orthopedic2 devices
• OVD — Orthopedic2 devices

• Z-2327-2015 — Titan Spine Endoskeleton Locking Bone Screw Assembly, which is part of the Endoskeleton TCS Interbody Fusion Device, spinal implant. Part Numbers / Product Description: 5302-3514 / 03.5 x 14mm Locking Screws; 5302-3516 / 03.5 x 16mm Locking Screws; 502-3518 / 03.5 x 18mm Locking Screws; 5302-3814 / 03.8 x 14mm Locking Screws; 5302-3816 / 03.8 x 16 mm Locking Screws; 5302-3818 / 03.8 x 18mm Locking Screws.Class II·Terminated·2015-07-20
• Z-1324-2015 — 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).Class II·Terminated·2015-02-20
• Z-0535-2013 — 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.Class II·Terminated·2012-10-19

Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.

• K173535 — Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody Fusion Device and Endoskeleton® TCS Interbody Fusion DeviceCode ODP·2018-02-13
• K170399 — Endoskeleton TO Interbody Fusion Device (IBD)Code MAX·2017-07-06
• K163269 — Endoskeleton(R) TAS Interbody Fusion Device / Endoskeleton(R) TAS Hyperlordotic Interbody Fusion DeviceCode OVD·2017-04-13
• K153122 — Endoskeleton(r) TCS SystemCode OVE·2015-12-14
• K151596 — Endoskeleton TCS Interbody Fusion DeviceCode OVE·2015-10-09
• K142940 — Endoskeleton TCS SystemCode OVE·2015-01-28
• K141953 — ENDOSKELETON; TA IBD AND VBR, TO AND TT, TAS, TC, TLCode MAX·2014-10-27
• K142589 — Endoskeleton TA IBD and VBR, Endoskeleton TO and TT, Endoskeleton TAS, Endoskeleton TAS, Endoskeleton TC, Endoskeleton TLCode MAX·2014-10-17
• K140055 — ENDOSKELETON(R) TL INTERBODY FUSION DEVICECode MAX·2014-07-02
• K111626 — ENDOSKELETON(R) TASCode OVD·2011-09-09
• K102067 — ENDOSKELETON TOCode MAX·2010-11-05
• K100889 — ENDOSKELETON TCCode ODP·2010-07-29
• K083714 — ENDOSKELETON TT INTERBODY FUSION DEVICE (IBD)Code MAX·2009-04-15
• K080615 — ENDOSKELETON TA INTERBODY FUSION DEVICE (IBD)Code MAX·2008-06-17