510(k) K111678 ยท HRS Plate, Fixation, Bone
ORTHO SOLUTIONS EXTREMITY FIXATION IMPLANTS FOR OSTEOSYSNTHESIS
| Applicant | Ortho Solutions Limited, Prior Lake MN, US |
| Decision | Substantially Equivalent, Feb 7, 2012 |
| Received | Jun 15, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111678
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 21, 2016 | Ortho Solutions Inc FPS 35mm x 3.5 mm non-locking screw Terminated |
HWC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.