510(k) K163595 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
IMPIX 3D Print Cages
| Applicant | Medicrea International SA, Rillieux-La-Pape, FR |
| Decision | Substantially Equivalent, Nov 13, 2017 |
| Received | Dec 21, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163595
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 24, 2023 | Medicrea International IMPIX 3D, REF numbers:
a) B242C09122810,
b) B242C10062810,
c) B242C10122810,
d) B242C11062810,
e) B242C11122810,
f) B242C12062810,
g) B242C12122810,
h) B242C12123310,
i) B242C13062810,
j) Open, Classified |
MAX | None listed |
| Oct 2, 2019 | Medicrea International Medicrea TLIF-B Holder, short intended for Intervertebral body fusion device
Catalog: Number A24200010 Terminated |
MAX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.