K192281 is an FDA 510(k) clearance for the 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, M-2 Anterior Plate System, MOUNTAINEER Laminoplasty System, PROFILE Anterior Thoracolumbar Plate System, UNIVERSITY PLATE Anterior System, VIPER F2 Facet Fixation System. This device is classified as a System, Facet Screw Spinal Device.
Submitted by Medos International SARL (Le Locle, CH). The FDA issued a Cleared decision on November 20, 2019, 90 days after receiving the submission on August 22, 2019.
This device falls under the Orthopedic FDA review panel.
| 510(k) Number | K192281 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 22, 2019 |
| Decision Date | November 20, 2019 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | MRW — System, Facet Screw Spinal Device |
| Device Class | — |