Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K190895
MOUNTAINEER OCT Spinal System, SUMMIT SI OCT Spinal Fixation System, SYMPHONY OCT System, SUMMIT Fixation System · Medos International SARL · decided 2019-07-18 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| SYMPHONY | 1020-40-146S | Medos International Sàrl | KWP NKG | 10705034529141 |
| SYMPHONY | 1020-03-120S | Medos International Sàrl | KWP NKG | 10705034526867 |
| SYMPHONY | 1020-63-030S | Medos International Sàrl | KWP NKG | 10705034525631 |
| SYMPHONY | 1020-21-353 | Medos International Sàrl | KWP NKG | 10705034518930 |
| SYMPHONY | 1020-21-351 | Medos International Sàrl | KWP NKG | 10705034518916 |
| SYMPHONY | 1020-40-814 | Medos International Sàrl | KWP NKG | 10705034518152 |
| SYMPHONY | 1020-81-420S | Medos International Sàrl | KWP NKG | 10705034523521 |
| SYMPHONY | 1020-50-220S | Medos International Sàrl | KWP NKG | 10705034523118 |
| SYMPHONY | 1020-45-228S | Medos International Sàrl | KWP NKG | 10705034521763 |
| MOUNTAINEER | 188328318 | Medos International Sàrl | KWP MNH MNI NKG | 10705034158570 |
| MOUNTAINEER | 188318316 | Medos International Sàrl | KWP MNI NKG | 10705034157191 |
| MOUNTAINEER | 188311013 | Medos International Sàrl | KWP MNI NKG | 10705034156613 |
| SYMPHONY | 1020-99-600S | Medos International Sàrl | KWP NKG | 10705034527758 |
| SYMPHONY | 1020-86-600S | Medos International Sàrl | KWP NKG | 10705034523743 |
| SYMPHONY | 1020-22-001 | Medos International Sàrl | KWP NKG | 10705034518978 |
| SYMPHONY | 1020-73-220 | Medos International Sàrl | KWP NKG | 10705034515786 |
| MOUNTAINEER | 188320434 | Medos International Sàrl | KWP MNI NKG | 10705034158280 |
| MOUNTAINEER | 188319416 | Medos International Sàrl | KWP MNI NKG | 10705034157856 |
| MOUNTAINEER | 188311104 | Medos International Sàrl | KWP MNI NKG | 10705034156682 |
| SYMPHONY | 1020-96-600S | Medos International Sàrl | KWP NKG | 10705034527635 |
| SYMPHONY | 1020-88-600S | Medos International Sàrl | KWP NKG | 10705034527352 |
| SYMPHONY | 1020-21-353S | Medos International Sàrl | KWP NKG | 10705034520117 |
| SYMPHONY | 1020-35-820 | Medos International Sàrl | KWP NKG | 10705034518497 |
| MOUNTAINEER | 188319420 | Medos International Sàrl | KWP MNI NKG | 10705034157870 |
| SYMPHONY | 1020-40-110 | Medos International Sàrl | KWP NKG | 10705034512228 |