Company · US
Titan Spine, LLC
FDA 510(k) clearances and medical device recalls filed under this name, 2008 to 2020. Name variants (Inc, Corp, punctuation) are merged.
19510(k) clearances (0 in 12 months)
3recalls (0 in 12 months)
3recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 7 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | 6 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 4 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 4 |
| MQP | Spinal Vertebral Body Replacement Device | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 8, 2020 | K191581 | Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion Device Titan Spine, Inc. | OVD |
| Aug 29, 2019 | K192054 | Endoskeleton TAS Plate Titan Spine, Inc. | OVD |
| Aug 16, 2019 | K192018 | Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic Interbody Fusion Device, Endoskeleton TO Titan Spine, Inc. | ODP |
| Aug 6, 2019 | K191565 | Endoskeleton TCS Interbody Fusion Device Titan Spine, Inc. | OVE |
| Feb 11, 2019 | K183557 | Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TO Interbody Fusion D Titan Spine, Inc. | ODP |
| Feb 13, 2018 | K173535 | Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody Fusion Device and Endoskeleton® TCS Titan Spine, LLC | ODP |
| Jul 6, 2017 | K170399 | Endoskeleton TO Interbody Fusion Device (IBD) Titan Spine, LLC | MAX |
| Apr 13, 2017 | K163269 | Endoskeleton(R) TAS Interbody Fusion Device / Endoskeleton(R) TAS Hyperlordotic Interbody Fusion Device Titan Spine, LLC | OVD |
| Dec 14, 2015 | K153122 | Endoskeleton(r) TCS System Titan Spine, LLC | OVE |
| Oct 9, 2015 | K151596 | Endoskeleton TCS Interbody Fusion Device Titan Spine, LLC | OVE |
| Jan 28, 2015 | K142940 | Endoskeleton TCS System Titan Spine, LLC | OVE |
| Oct 27, 2014 | K141953 | ENDOSKELETON; TA IBD AND VBR, TO AND TT, TAS, TC, TL Titan Spine, LLC | MAX |
| Oct 17, 2014 | K142589 | Endoskeleton TA IBD and VBR, Endoskeleton TO and TT, Endoskeleton TAS, Endoskeleton TAS, Endoskeleton TC, Endoskeleton T Titan Spine, LLC | MAX |
| Jul 2, 2014 | K140055 | ENDOSKELETON(R) TL INTERBODY FUSION DEVICE Titan Spine, LLC | MAX |
| Sep 9, 2011 | K111626 | ENDOSKELETON(R) TAS Titan Spine, LLC | OVD |
| Nov 5, 2010 | K102067 | ENDOSKELETON TO Titan Spine, LLC | MAX |
| Jul 29, 2010 | K100889 | ENDOSKELETON TC Titan Spine, LLC | ODP |
| Apr 15, 2009 | K083714 | ENDOSKELETON TT INTERBODY FUSION DEVICE (IBD) Titan Spine, LLC | MAX |
| Jun 17, 2008 | K080615 | ENDOSKELETON TA INTERBODY FUSION DEVICE (IBD) Titan Spine, LLC | MAX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 3, 2015 | TITAN SPINE, LLC 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 Locki Terminated |
OVE | K142940 |
| Mar 26, 2015 | TITAN SPINE, LLC 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 Terminated |
OVE | K142940 |
| Dec 17, 2012 | TITAN SPINE, LLC 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
2107-02 Terminated |
MQP | K032812 |