510(k) K100544 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
IMPIX LUMBAR INTERBODY DEVICE
| Applicant | Medicrea Technologies, Round Rock TX, US |
| Decision | Substantially Equivalent, Jul 22, 2010 |
| Received | Feb 25, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K100544
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 24, 2023 | Medicrea International IMPIX DLIF, REF numbers:
a) B16123509,
b) B16123511,
c) B16124009,
d) B16124013,
e) B16124509,
f) B16124511,
g) B16124513,
h) B16164009,
i) B16164013,
j) B16165009,
k) B16165013; interver Open, Classified |
MAX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.