TITAN SPINE, LLC
FDA Regulatory Profile
TITAN SPINE, LLC appears in FDA public data with 3 recalls, 19 510(k) clearances, 3 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2327-2015, Class II) was initiated on July 20, 2015. Its most recent 510(k) clearance was granted on January 8, 2020.
Summary
- Total Recalls
- 3
- 510(k) Clearances
- 19
- Inspections
- 3
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2327-2015 | Class II | Titan Spine Endoskeleton Locking Bone Screw Assembly, which is part of the Endoskeleton TCS Interbod | July 20, 2015 |
| Z-1324-2015 | Class II | Endo TCS Driver Straight Hexalobe #6 P/N 5210-1004, Non-Sterile, Manufactured by Titan Spine, LLC. | February 20, 2015 |
| Z-0535-2013 | Class II | Titan Spine Endoskeleton TA Implant products. 2107-0118 18mm Standard Endoskeleton Implant VBR | October 19, 2012 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K191581 | Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion Device | January 8, 2020 |
| K192054 | Endoskeleton TAS Plate | August 29, 2019 |
| K192018 | Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic Interbody Fusion Dev | August 16, 2019 |
| K191565 | Endoskeleton TCS Interbody Fusion Device | August 6, 2019 |
| K183557 | Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® T | February 11, 2019 |
| K173535 | Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody Fusion Device a | February 13, 2018 |
| K170399 | Endoskeleton TO Interbody Fusion Device (IBD) | July 6, 2017 |
| K163269 | Endoskeleton(R) TAS Interbody Fusion Device / Endoskeleton(R) TAS Hyperlordotic Interbody Fusion Dev | April 13, 2017 |
| K153122 | Endoskeleton(r) TCS System | December 14, 2015 |
| K151596 | Endoskeleton TCS Interbody Fusion Device | October 9, 2015 |
| K142940 | Endoskeleton TCS System | January 28, 2015 |
| K141953 | ENDOSKELETON; TA IBD AND VBR, TO AND TT, TAS, TC, TL | October 27, 2014 |
| K142589 | Endoskeleton TA IBD and VBR, Endoskeleton TO and TT, Endoskeleton TAS, Endoskeleton TAS, Endoskeleto | October 17, 2014 |
| K140055 | ENDOSKELETON(R) TL INTERBODY FUSION DEVICE | July 2, 2014 |
| K111626 | ENDOSKELETON(R) TAS | September 9, 2011 |
| K102067 | ENDOSKELETON TO | November 5, 2010 |
| K100889 | ENDOSKELETON TC | July 29, 2010 |
| K083714 | ENDOSKELETON TT INTERBODY FUSION DEVICE (IBD) | April 15, 2009 |
| K080615 | ENDOSKELETON TA INTERBODY FUSION DEVICE (IBD) | June 17, 2008 |