# Premia Spine, Ltd.

- Location (FDA's records): Ramat Poleg, Netanya, IL
- FDA decisions: 7 (2015–2023): 6 510(k) clearances and 1 original PMA approval
- Product codes: NKB (5), OLO (1), QWK (1)
- 510(k) review time since 2016: median 54 days, against 72 for FDA's reviews in the same codes and years (4 of 5 faster)
- Predicates its devices cite: 7 (4 its own); citations of its devices by later devices: 4 (4 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Spine Wave, Inc.: 1 (https://510kreport.com/company/spine-wave)
- Choicespine, LP: 1 (https://510kreport.com/company/choicespine)
- Medtronic Sofamor Danek USA, Inc.: 1 (https://510kreport.com/company/medtronic-sofamor-danek-usa)

## Its most-cited devices
- K150380: ProMIS Fixation System (2015), cited by 3
- K231844: ProMIS™ Fixation System (2023), cited by 1

## Recent decisions
- K232719: ProMIS Extension Rod System (Nov 21, 2023)
- K231844: ProMIS™ Fixation System (Jul 7, 2023)
- P220002: TOPS™ System (Jun 15, 2023)
- K191854: Premia Spine XL Instruments (Oct 8, 2019)
- K182598: VersaLink™ Fixation System (Nov 13, 2018)
- K170061: ProMIS™ Fixation System (Feb 2, 2017)
- K150380: ProMIS Fixation System (Jul 17, 2015)

Source page: https://510kreport.com/company/premia-spine