Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) 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 Approval2023-11-21
TypeNumberDevice NameCodeDate
510(k) K232719 ProMIS Extension Rod System NKB 2023-11-21 View
PMA P220002 Prosthesis, posterior spinal elements QWK 2023-10-27 View
510(k) K231844 ProMIS™ Fixation System NKB 2023-07-07 View
510(k) K191854 Premia Spine XL Instruments OLO 2019-10-08 View
510(k) K182598 VersaLink™ Fixation System NKB 2018-11-13 View
510(k) K170061 ProMIS™ Fixation System NKB 2017-02-02 View