510(k) K142940 ยท OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
Endoskeleton TCS System
| Applicant | Titan Spine, LLC, Mequon WI, US |
| Decision | Substantially Equivalent, Jan 28, 2015 |
| Received | Oct 9, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K142940
| 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 | None listed |
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.