510(k) K100575 ยท MNI Orthosis, Spinal Pedicle Fixation
LDR SPINE USA SPINE TUNE TL SPINE SYSTEM
| Applicant | Ldr Spine USA, Austin TX, US |
| Decision | Substantially Equivalent, Mar 31, 2010 |
| Received | Mar 1, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K100575
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.