The following data is part of a premarket notification filed by Medos International Sarl with the FDA for Crossover Cross Connectors, Depuy Pulse Thoracolumbar Screw System, Expedium Fenestrated Screw System, Expedium Sfx Cross Connectors, Expedium Spine System, Expedium Verse Spine System, E-z Link Cross Connectors, Isola Spine System, Monarch Spine Sys.
| Device ID | K191212 |
| 510k Number | K191212 |
| Device Name: | CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated Screw System, EXPEDIUM SFX Cross Connectors, EXPEDIUM Spine System, EXPEDIUM VERSE Spine System, E-Z Link Cross Connectors, ISOLA Spine System, MONARCH Spine Sys |
| Classification | Growing Rod System |
| 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 | PGM |
| Subsequent Product Code | JDN |
| Subsequent Product Code | JDQ |
| Subsequent Product Code | KWP |
| Subsequent Product Code | KWQ |
| Subsequent Product Code | NKB |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-06 |
| Decision Date | 2019-09-24 |
| Summary: | summary |