Premia Spine, Ltd.
Medical device manufacturer in Netanya, Ramat Pole, Isra.
6510(k) clearances
1PMA approvals
1recalls
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K232719 | ProMIS Extension Rod SystemNKB · Traditional | 11/21/2023SE |
| K231844 | ProMIS Fixation SystemNKB · Special | 07/07/2023SE |
| K191854 | Premia Spine XL InstrumentsOLO · Traditional | 10/08/2019SE |
| K182598 | VersaLink Fixation SystemNKB · Traditional | 11/13/2018SE |
| K170061 | ProMIS Fixation SystemNKB · Special | 02/02/2017SE |
| K150380 | ProMIS Fixation SystemNKB · Traditional | 07/17/2015SE |
PMA approvals
- P220002 TOPS System · 06/15/2023 · 11 supplements
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-2516-2025 Class II | TOPS Inserter, part of the TOPS System Instrument Set used for implantation of the TOPS…Potential for missing pins at tip of inserter. | 07/16/2025Open, Classified |