Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Premia Spine, Ltd.

FDA 510(k) & PMA Approved Devices — 6 products

Total Devices6
Categories3
Latest FDA decision2026-05-29
TypeNumberDevice NameCodeDateActions
PMA P220002 Prosthesis, posterior spinal elementsQWK2026-05-29 View
510(k) K232719 ProMIS Extension Rod SystemNKB2023-11-21 View
510(k) K231844 ProMIS™ Fixation SystemNKB2023-07-07 View
510(k) K191854 Premia Spine XL InstrumentsOLO2019-10-08 View
510(k) K182598 VersaLink™ Fixation SystemNKB2018-11-13 View
510(k) K170061 ProMIS™ Fixation SystemNKB2017-02-02 View
↑