510(k) K132644 ยท MNI Orthosis, Spinal Pedicle Fixation
LOSPA IS PEDICLE SCREW (MONOAXIAL & POLYAXIAL), LOSPA IS ROD- STRAIGHT (STANDARD), LOSPA IS ROD- PRE BENT (STANDARD & BU
| Applicant | Corentec Co., Ltd., Seocho Gu, Seoul, KR |
| Decision | Substantially Equivalent, Sep 19, 2013 |
| Received | Aug 26, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K132644
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.