510(k) K141784 ยท HRS Plate, Fixation, Bone
ORTHO SOLUTIONS ULTOS PLATING SYSTEM
| Applicant | Ortho Solutions Limited, Prior Lake MN, US |
| Decision | Substantially Equivalent, Jul 23, 2014 |
| Received | Jul 2, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K141784
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 21, 2025 | CPM Medical Consultants, LLC. Fuse ULTRA Foot Plating System Instructions for Use.
Models: OS200400, OS200401, OS328017, OS200020L, OS200025L, OS200120L, OS200125, OS200125L, OS200135, OS200324, OS200325, OS200326, OS328026, OS32 Open, Classified |
HRS | None listed |
| Oct 6, 2015 | Ortho Solutions Inc Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile
Orthopaedic Bone Terminated |
HWC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.