510(k) K131981 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
CEZANNE II INTERBODY FUSION SYSTEM
| Applicant | Accel Spine, Dallas TX, US |
| Decision | Substantially Equivalent, Oct 9, 2013 |
| Received | Jun 28, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K131981
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 21, 2019 | CTL Medical Corporation CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L26, H7mm, Part #018.1307. Completed |
MAX | None listed |
| Aug 21, 2019 | CTL Medical Corporation CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L30, H7mm, Part #018.1907. Completed |
MAX | None listed |
| Aug 21, 2019 | CTL Medical Corporation CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L26, H8mm, Part #018.1308. Completed |
MAX | None listed |
| Aug 21, 2019 | CTL Medical Corporation CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L30, H8mm, Part #018.1908. Completed |
MAX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.