Innovasis, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E Navigation Instruments), Innovasis Navigation Instruments, Vector™ Pedicle Screw System
33
Total
32
Cleared
0
Denied
FDA 510(k) Regulatory Record - Innovasis, Inc. Orthopedic ✕
31 devices
Cleared
Jul 23, 2025
Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the...
Orthopedic
106d
Cleared
Mar 24, 2025
Innovasis Navigation Instruments
Orthopedic
61d
Cleared
May 20, 2024
Vector™ Pedicle Screw System
Orthopedic
14d
Cleared
Oct 17, 2023
HAtetracell™-C Titanium Cervical IBF System
Orthopedic
111d
Cleared
May 02, 2023
Excella Navigation Instruments
Orthopedic
161d
Cleared
Dec 12, 2022
Matrix HA Fusion Porous Cervical IBF System
Orthopedic
20d
Cleared
Aug 26, 2022
HAcancellous PEEK-C Porous HA PEEK Cervical IBF System
Orthopedic
154d
Cleared
Oct 15, 2021
AxTiHA Stand-Alone ALIF System
Orthopedic
29d
Cleared
Jul 15, 2020
TxTiHA IBF System, AxTiHA Stand-Alone ALIF System
Orthopedic
30d
Cleared
Nov 08, 2019
Oryx Cervical Plate System
Orthopedic
100d
Cleared
Sep 24, 2019
Innovasis Gibralt Spine System
Orthopedic
26d
Cleared
Jun 28, 2019
TxTi IBF System
Orthopedic
235d