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Spineart SA

FDA 510(k) & PMA Approved Devices — 13 products

Total Devices13
Categories7
Latest FDA decision2026-08-14
TypeNumberDevice NameCodeDateActions
510(k) K262639 BAGUERA® C Cervical Disc Surgical InstrumentsQLQ2026-08-14 View
510(k) K261205 SPINEART Navigation Instrument SystemOLO2026-07-29 View
510(k) K253966 PERLA® TL Posterior Thoraco-lumbar Fixation SystemNKB2026-05-01 View
510(k) K254158 SPINEART Navigation Instrument SystemOLO2026-04-09 View
510(k) K242933 SPINEART Navigation Instrument SystemOLO2025-06-18 View
510(k) K242890 SPINEART Navigation Instrument SystemOLO2025-03-07 View
510(k) K242589 Scarlet® AL-TMAX2024-10-23 View
510(k) K241644 SPINEART Navigation Instrument SystemOLO2024-08-07 View
510(k) K241321 Juliet® Ti LL Lumbar Interbody DeviceOVD2024-07-18 View
510(k) K240699 SCARLET® AC-TiOVE2024-05-10 View
510(k) K231069 PERLA® TL Posterior Thoraco-lumbar Fixation SystemNKB2023-10-25 View
510(k) K230583 Tryptik TiODP2023-03-22 View
510(k) K183630 SPINEART Navigation Instrument SystemOLO2019-06-10 View