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TITAN SPINE, LLC

FDA Regulatory Profile

Summary

Total Recalls
3
510(k) Clearances
19
Inspections
3
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2327-2015Class IITitan Spine Endoskeleton Locking Bone Screw Assembly, which is part of the Endoskeleton TCS InterbodJuly 20, 2015
Z-1324-2015Class IIEndo TCS Driver Straight Hexalobe #6 P/N 5210-1004, Non-Sterile, Manufactured by Titan Spine, LLC. February 20, 2015
Z-0535-2013Class IITitan Spine Endoskeleton TA Implant products. 2107-0118 18mm Standard Endoskeleton Implant VBR October 19, 2012

Recent 510(k) Clearances

K-NumberDeviceDate
K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion DeviceJanuary 8, 2020
K192054Endoskeleton TAS PlateAugust 29, 2019
K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic Interbody Fusion DevAugust 16, 2019
K191565Endoskeleton TCS Interbody Fusion DeviceAugust 6, 2019
K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TFebruary 11, 2019
K173535Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody Fusion Device aFebruary 13, 2018
K170399Endoskeleton TO Interbody Fusion Device (IBD)July 6, 2017
K163269Endoskeleton(R) TAS Interbody Fusion Device / Endoskeleton(R) TAS Hyperlordotic Interbody Fusion DevApril 13, 2017
K153122Endoskeleton(r) TCS SystemDecember 14, 2015
K151596Endoskeleton TCS Interbody Fusion DeviceOctober 9, 2015
K142940Endoskeleton TCS SystemJanuary 28, 2015
K141953ENDOSKELETON; TA IBD AND VBR, TO AND TT, TAS, TC, TLOctober 27, 2014
K142589Endoskeleton TA IBD and VBR, Endoskeleton TO and TT, Endoskeleton TAS, Endoskeleton TAS, EndoskeletoOctober 17, 2014
K140055ENDOSKELETON(R) TL INTERBODY FUSION DEVICEJuly 2, 2014
K111626ENDOSKELETON(R) TASSeptember 9, 2011
K102067ENDOSKELETON TONovember 5, 2010
K100889ENDOSKELETON TCJuly 29, 2010
K083714ENDOSKELETON TT INTERBODY FUSION DEVICE (IBD)April 15, 2009
K080615ENDOSKELETON TA INTERBODY FUSION DEVICE (IBD)June 17, 2008