# Innovasis, Inc.

- Location (FDA's records): Salt Lake City, UT
- FDA decisions: 35 (2004–2025): 35 510(k) clearances
- Names in FDA's records: Innovasis, Inc. (33); Innovasis (2)
- Product codes: MAX (7), ODP (5), OVD (4), NKB (4), KWQ (3), OLO (3), FST (1), GWO (1), KWP (1), PEK (1), NKG (1), JDK (1)
- 510(k) review time since 2016: median 91 days, against 105 for FDA's reviews in the same codes and years (14 of 21 faster)
- Predicates its devices cite: 89 (34 its own); citations of its devices by later devices: 52 (34 its own)
- Recalls linked to its devices: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Medtronic Sofamor Danek: 5 (https://510kreport.com/company/medtronic-sofamor-danek)
- Nu Vasive, Incorporated: 3 (https://510kreport.com/company/nu-vasive)
- Synthes Spine: 3 (https://510kreport.com/company/synthes-spine)
- Spinal Concepts, Inc.: 3 (https://510kreport.com/company/spinal-concepts)
- Nuvasive, Inc.: 2 (https://510kreport.com/company/nuvasive)
- Medtronic Sofamor Danek USA, Inc.: 2 (https://510kreport.com/company/medtronic-sofamor-danek-usa)
- Globus Medical, Inc.: 2 (https://510kreport.com/company/globus-medical)
- Depuyacromed: 2 (https://510kreport.com/company/depuyacromed)

## Firms that cite its devices most
- Alphatec Spine, Inc.: 3 (https://510kreport.com/company/alphatec-spine)
- INNO Holdings Inc. DBA Innovasis: 2 (https://510kreport.com/company/inno-holdings-dba-innovasis)
- K2m, Inc.: 1 (https://510kreport.com/company/k2m)
- GS Medical Co., Ltd.: 1 (https://510kreport.com/company/gs-medical)
- Promethean Restorative, LLC: 1 (https://510kreport.com/company/promethean-restorative)
- Orthomod, LLC: 1 (https://510kreport.com/company/orthomod)
- Curiteva, Inc.: 1 (https://510kreport.com/company/curiteva)
- Spineworxx AG: 1 (https://510kreport.com/company/spineworxx)

## Its most-cited devices
- K201614: TxTiHA IBF System, AxTiHA Stand-Alone ALIF System (2020), cited by 6
- K181115: CxHA PEEK Cervical IBF System (2018), cited by 5
- K180078: Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF System (2018), cited by 4
- K162236: Ax Stand-Alone ALIF System (2017), cited by 3
- K220875: HAcancellous PEEK-C Porous HA PEEK Cervical IBF System (2022), cited by 3
- K182139: AXTi Titanium Stand-Alone ALIF System (2019), cited by 3

## Recent decisions
- K250076: Endeavor™ Stand-Alone Cervical IBF System (Sep 25, 2025)
- K251073: Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E Navigation Instruments) (Jul 23, 2025)
- K250603: AxTiHA® Stand-Alone ALIF System (Mar 24, 2025)
- K250182: Innovasis Navigation Instruments (Mar 24, 2025)
- K241276: Vector™ Pedicle Screw System (May 20, 2024)
- K231899: HAtetracell™-C Titanium Cervical IBF System (Oct 17, 2023)
- K223511: Excella Navigation Instruments (May 2, 2023)
- K223510: Matrix HA Fusion Porous Cervical IBF System (Dec 12, 2022)

Source page: https://510kreport.com/company/innovasis