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Innovasis, Inc.

FDA 510(k) & PMA Approved Devices — 20 products

Total Devices20
Categories9
Latest FDA decision2025-07-23
TypeNumberDevice NameCodeDateActions
510(k) K251073 Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E Navigation Instruments)OLO2025-07-23 View
510(k) K250182 Innovasis Navigation InstrumentsOLO2025-03-24 View
510(k) K241276 Vector™ Pedicle Screw SystemNKB2024-05-20 View
510(k) K231899 HAtetracell™-C Titanium Cervical IBF SystemODP2023-10-17 View
510(k) K223511 Excella Navigation InstrumentsOLO2023-05-02 View
510(k) K223510 Matrix HA Fusion Porous Cervical IBF SystemODP2022-12-12 View
510(k) K220875 HAcancellous PEEK-C Porous HA PEEK Cervical IBF SystemODP2022-08-26 View
510(k) K212967 AxTiHA Stand-Alone ALIF SystemOVD2021-10-15 View
510(k) K201614 TxTiHA IBF System, AxTiHA Stand-Alone ALIF SystemMAX2020-07-15 View
510(k) K200874 TruView Light Cable, TruView Lateral Retractor Light Cable, Bifurcated Light Cable With Universal EndFST2020-06-30 View
510(k) K192049 Oryx Cervical Plate SystemKWQ2019-11-08 View
510(k) K192354 Innovasis Gibralt Spine SystemNKG2019-09-24 View
510(k) K183064 TxTi IBF SystemMAX2019-06-28 View
510(k) K182139 AXTi Titanium Stand-Alone ALIF SystemOVD2019-06-21 View
510(k) K190684 LxHA PEEK Lateral IBF SystemMAX2019-06-17 View
510(k) K181115 CxHA PEEK Cervical IBF SystemODP2018-07-16 View
510(k) K181063 Kestrel™ Buttress Plate SystemKWQ2018-07-13 View
510(k) K180078 Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF SystemMAX2018-04-17 View
510(k) K162236 Ax Stand-Alone ALIF SystemOVD2017-04-20 View
510(k) K162143 FixxSure® X-LinkMNH2016-09-23 View
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