510(k) K192281 ยท MRW System, Facet Screw Spinal Device
AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine System, BOWTI Anterior Buttress Staple Spinal System, DISCOVERY Screw System, EXPEDIUM Anterior Spine System, FRONTIER Anterior Scoliosis System, KANEDA Anterior Scoliosis System, KANEDA SR Anterior Spinal System
| Applicant | Medos International SARL, Le Locle, CH |
| Decision | Substantially Equivalent, Nov 20, 2019 |
| Received | Aug 22, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192281
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.