510(k) K110497 ยท MNH Orthosis, Spondylolisthesis Spinal Fixation
PASS LP SPINAL SYSTEM
| Applicant | Medicrea International, Round Rock TX, US |
| Decision | Substantially Equivalent, Sep 26, 2011 |
| Received | Feb 22, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K110497
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 24, 2023 | Medicrea International PASS LP, REF numbers:
a) B02315535Z,
b) B02315540Z,
c) B02315545Z,
d) B02315550Z,
e) B02316535Z,
f) B02316540Z,
g) B02316545Z,
h) B02316550Z,
i) B02317540Z,
j) B02317545Z,
k) B02317550Z; i Open, Classified |
MNI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.