The following data is part of a premarket notification filed by Medos International Sarl with the FDA for 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 .
| Device ID | K192281 |
| 501k Number | K192281 |
| Device Name: | 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 |
| Classification | System, Facet Screw Spinal Device |
| Applicant | Medos International SARL Chemin-Blanc 38 Le Locle, CH 2400 |
| Contact | Sergio M. Cordeiro |
| Correspondent | Sergio M. Cordeiro DePuy Synthes Spine 325 Paramount Drive Raynham, MA 02767 |
| Product Code | MRW |
| Subsequent Product Code | KWQ |
| Subsequent Product Code | NKB |
| Subsequent Product Code | NQW |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Regulation Medical Specialty | 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices |
| 501k Review Panel | Orthopedic |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-22 |
| Decision Date | 2019-11-20 |