510(k) K141953 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
ENDOSKELETON; TA IBD AND VBR, TO AND TT, TAS, TC, TL
| Applicant | Titan Spine, LLC, Bartlett TN, US |
| Decision | Substantially Equivalent, Oct 27, 2014 |
| Received | Jul 18, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K141953
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 2, 2021 | Medtronic Sofamor Danek USA Inc Endoskeleton" TAS Interbody System with Titan nanoLOCK" Surface Technology, Nanolock 12 Dg Interbody, Large, 12mm Terminated |
OVD | None listed |
| Mar 17, 2021 | Medtronic Sofamor Danek USA, Inc Endoskeleton TC Interbody System with Titan nanoLOCK Surface Technology, 6 Degree, Large, 8 mm, Product Number 5146-1608-N - Product Usage: indicated to be used with supplemental fixation cleared by t Terminated |
MAX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.