510(k) K153735 ยท NQW Orthosis, Spine, Plate, Laminoplasty, Metal
Release Laminoplasty Fixation System
| Applicant | Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.), Marquette MI, US |
| Decision | Substantially Equivalent, Jan 21, 2016 |
| Received | Dec 28, 2015 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K153735
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.