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.

Spineart

FDA 510(k) & PMA Approved Devices — 23 products

Total Devices23
Categories9
Latest Approval2023-06-23
TypeNumberDevice NameCodeDate
510(k) K230774 PERLA® TL System; TEKTONA® HV US Bone Cement PML 2023-06-23 View
510(k) K213470 PERLA® TL Posterior Osteosynthesis System NKB 2022-01-21 View
510(k) K210472 SPINEART Navigation Instrument System OLO 2021-03-19 View
510(k) K203506 PERLA® TL posterior osteosynthesis system NKB 2021-01-15 View
510(k) K203222 PERLA TL Posterior Osteosynthesis System NKB 2020-12-17 View
510(k) K200571 PERLA® Posterior Occipito-Cervico-Thoracic Fixation System NKG 2020-05-01 View
510(k) K200312 Tryptik Ti ODP 2020-04-06 View
510(k) K193396 PERLA® TL posterior osteosynthesis system NKB 2020-02-05 View
510(k) K192993 SCARLET AL-T OVD 2020-01-22 View
510(k) K190877 Juliet® Ti LL Lumbar Interbody Device OVD 2019-05-29 View
510(k) K190322 SCARLET® AC-T Secured Anterior Cervical Cage ODP 2019-03-04 View
510(k) K190071 Perla® Posterior Cervico-Thoracic Fixation System NKG 2019-02-25 View
510(k) K181818 Scarlet AL-T OVD 2018-10-09 View
510(k) K181203 Juliet Ti MAX 2018-06-28 View
510(k) K171797 TRYPTIK2 C-Plate Anterior Cervical Plate System KWQ 2018-02-26 View
510(k) K173702 Juliet Ti LL MAX 2018-01-03 View
510(k) K172065 SCARLET AC-T ODP 2017-09-29 View
510(k) K172101 ROMEO® 2 Posterior Osteosynthesis System NKB 2017-09-26 View
510(k) K161888 JULIET® LL Lateral Lumbar Cage MAX 2016-09-12 View
510(k) K153621 Juliet® Ti MAX 2016-07-15 View
510(k) K153042 TRYPTIK2C-plate Anterior Cervical Plate System KWQ 2016-03-28 View
510(k) K153386 Perla Posterior Cervico-Thoracic Fixation system NKG 2016-01-25 View
510(k) K151104 OTELO LL GAD 2016-01-06 View
↑