510(k) K100484 ยท ODP Intervertebral Fusion Device With Bone Graft, Cervical
IMPIX MANTA CERVICAL INTERBODY DEVICE
| Applicant | Medicrea, Round Rock TX, US |
| Decision | Substantially Equivalent, Mar 16, 2010 |
| Received | Feb 18, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K100484
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 24, 2023 | Medicrea International IMPIX MANTA, REF numbers:
a) A20150407,
b) A20250407,
c) A20350567,
d) B20181743,
e) B20181753,
f) B20181763,
g) B20181773,
h) B20181943,
i) B20181953,
j) B20181963,
k) B20181973,
l) B201 Open, Classified |
ODP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.