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Innovasis, Inc

FDA Regulatory Profile

Summary

Total Recalls
6
510(k) Clearances
35
Inspections
5
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-3163-2024Class IITxHA PEEK IBF/TxTiHA IBF System REF BTA-151 i. TxHA The Innovasis TxHA PEEK IBF System is an inAugust 14, 2024
Z-2062-2020Class IIOryx Cervical Screw Caddy, Model Number BTA-172, as part of the Oryx Cervical Plate System - ProductApril 7, 2020
Z-0644-2018Class IIExcella II Polyaxial Pedicle Screw used as a pedicle screw system in skeletally mature patients, is January 8, 2018
Z-2153-2017Class IIOpteryx Variable Rescue Screw, Part #CP2214, UDI: *+M711CP22140/$$801716012*. Packaged in heat-sealMay 5, 2017
Z-0662-2016Class IIExcella II Rod Cat. No.: SR 55100 5.5 x 100 mm LOT 1502 and Excella II Rod Cat. No.: SR 55110 5.5 December 7, 2015
Z-2067-2014Class IIExcella II Standard Pedicle Screw, Catalog No. E2S47525 and E2S47535, 4.75 mm x 25 mm. For spinal fiJuly 7, 2014

Recent 510(k) Clearances

K-NumberDeviceDate
K250076Endeavor™ Stand-Alone Cervical IBF SystemSeptember 25, 2025
K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E Navigation IJuly 23, 2025
K250603AxTiHA® Stand-Alone ALIF SystemMarch 24, 2025
K250182Innovasis Navigation InstrumentsMarch 24, 2025
K241276Vector™ Pedicle Screw SystemMay 20, 2024
K231899HAtetracell™-C Titanium Cervical IBF SystemOctober 17, 2023
K223511Excella Navigation InstrumentsMay 2, 2023
K223510Matrix HA Fusion Porous Cervical IBF SystemDecember 12, 2022
K220875HAcancellous PEEK-C Porous HA PEEK Cervical IBF SystemAugust 26, 2022
K212967AxTiHA Stand-Alone ALIF SystemOctober 15, 2021
K201614TxTiHA IBF System, AxTiHA Stand-Alone ALIF SystemJuly 15, 2020
K200874TruView Light Cable, TruView Lateral Retractor Light Cable, Bifurcated Light Cable With Universal EnJune 30, 2020
K192049Oryx Cervical Plate SystemNovember 8, 2019
K192354Innovasis Gibralt Spine SystemSeptember 24, 2019
K183064TxTi IBF SystemJune 28, 2019
K182139AXTi Titanium Stand-Alone ALIF SystemJune 21, 2019
K190684LxHA PEEK Lateral IBF SystemJune 17, 2019
K181115CxHA PEEK Cervical IBF SystemJuly 16, 2018
K181063Kestrel™ Buttress Plate SystemJuly 13, 2018
K180078Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF SystemApril 17, 2018