510(k) K083798 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
IMPIX ALIF LUMBAR IBF, IMPIX ALIF-D LUMBAR IBF, IMPIX TLIF LUMBAR IBF
| Applicant | Medicrea Technologies, Douglassville PA, US |
| Decision | Substantially Equivalent, May 19, 2010 |
| Received | Dec 22, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083798
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 24, 2023 | Medicrea International IMPIX ALIF, REF numbers:
a) B15111209,
b) B15111212,
c) B15111409,
d) B15111412; intervertebral fusion device - lumbar Open, Classified |
MAX | None listed |
| Aug 24, 2023 | Medicrea International IMPIX TLIF, REF numbers:
a) B15130607S,
b) B15130609S,
c) B15130611S,
d) B15130613S,
e) B15130615S,
f) B15900806,
g) B15900906,
h) B15901006,
i) B15901106,
j) B15901206,
k) B15901306; inte Open, Classified |
MAX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.