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Spineart

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

Total Devices23
Categories9
Latest FDA decision2023-06-23
TypeNumberDevice NameCodeDateActions
510(k) K230774 PERLA® TL System; TEKTONA® HV US Bone CementPML2023-06-23 View
510(k) K213470 PERLA® TL Posterior Osteosynthesis SystemNKB2022-01-21 View
510(k) K210472 SPINEART Navigation Instrument SystemOLO2021-03-19 View
510(k) K203506 PERLA® TL posterior osteosynthesis systemNKB2021-01-15 View
510(k) K203222 PERLA TL Posterior Osteosynthesis SystemNKB2020-12-17 View
510(k) K200571 PERLA® Posterior Occipito-Cervico-Thoracic Fixation SystemNKG2020-05-01 View
510(k) K200312 Tryptik TiODP2020-04-06 View
510(k) K193396 PERLA® TL posterior osteosynthesis systemNKB2020-02-05 View
510(k) K192993 SCARLET AL-TOVD2020-01-22 View
510(k) K190877 Juliet® Ti LL Lumbar Interbody DeviceOVD2019-05-29 View
510(k) K190322 SCARLET® AC-T Secured Anterior Cervical CageODP2019-03-04 View
510(k) K190071 Perla® Posterior Cervico-Thoracic Fixation SystemNKG2019-02-25 View
510(k) K181818 Scarlet AL-TOVD2018-10-09 View
510(k) K181203 Juliet TiMAX2018-06-28 View
510(k) K171797 TRYPTIK2 C-Plate Anterior Cervical Plate SystemKWQ2018-02-26 View
510(k) K173702 Juliet Ti LLMAX2018-01-03 View
510(k) K172065 SCARLET AC-TODP2017-09-29 View
510(k) K172101 ROMEO® 2 Posterior Osteosynthesis SystemNKB2017-09-26 View
510(k) K161888 JULIET® LL Lateral Lumbar CageMAX2016-09-12 View
510(k) K153621 Juliet® TiMAX2016-07-15 View

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