The following data is part of a premarket notification filed by Medos International Sarl with the FDA for Sypmhony™ Oct System.
| Device ID | K192014 |
| 510k Number | K192014 |
| Device Name: | SYPMHONY™ OCT 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 |
| CFR Regulation Number | 888.3075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-29 |
| Decision Date | 2020-01-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10705034520247 | K192014 | 000 |
| 10705034520230 | K192014 | 000 |
| 10705034520223 | K192014 | 000 |
| 10705034520216 | K192014 | 000 |
| 10705034520209 | K192014 | 000 |
| 10705034520193 | K192014 | 000 |