The following data is part of a premarket notification filed by Medos International Sarl with the FDA for Mountaineer Oct Spinal System, Summit Si Oct Spinal Fixation System, Symphony Oct System, Summit Fixation System.
| Device ID | K190895 |
| 510k Number | K190895 |
| Device Name: | MOUNTAINEER OCT Spinal System, SUMMIT SI OCT Spinal Fixation System, SYMPHONY OCT System, SUMMIT Fixation System |
| Classification | Posterior Cervical Screw System |
| Applicant | Medos International Sarl Chemin-Blanc 38 Le Locle, CH 2400 |
| Contact | Sheree Geller |
| Correspondent | Sheree Geller Depuy Synthes Spine 325 Paramount Drive Raynham, MA 02767 |
| Product Code | NKG |
| Subsequent Product Code | HRS |
| Subsequent Product Code | HWC |
| Subsequent Product Code | KWP |
| CFR Regulation Number | 888.3075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-05 |
| Decision Date | 2019-07-18 |