# Spineex, Inc.

- Location (FDA's records): Fremont, CA
- FDA decisions: 3 (2018–2020): 3 510(k) clearances
- Product codes: MAX (3)
- 510(k) review time since 2016: median 31 days, against 114 for FDA's reviews in the same codes and years (2 of 3 faster)
- Predicates its devices cite: 8 (3 its own); citations of its devices by later devices: 6 (3 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Coalign Innovations, Inc.: 1 (https://510kreport.com/company/coalign-innovations)
- Globus Medical, Inc.: 1 (https://510kreport.com/company/globus-medical)
- Expanding Orthopedics, Inc.: 1 (https://510kreport.com/company/expanding-orthopedics)
- Nuvasive, Inc.: 1 (https://510kreport.com/company/nuvasive)
- Lanx, Inc.: 1 (https://510kreport.com/company/lanx)

## Firms that cite its devices most
- Adcura, Inc.: 3 (https://510kreport.com/company/adcura)

## Its most-cited devices
- K181531: SpineEX Sagittae Lateral Lumbar Interbody Fusion Devices (2018), cited by 3
- K190193: SpineEX Sagittae® Lateral Lumbar Interbody Fusion Devices (2019), cited by 2
- K200816: SpineEX Sagittae Lateral Lumbar Interbody Fusion Devices (2020), cited by 1

## Recent decisions
- K200816: SpineEX Sagittae Lateral Lumbar Interbody Fusion Devices (Apr 30, 2020)
- K190193: SpineEX Sagittae® Lateral Lumbar Interbody Fusion Devices (Mar 4, 2019)
- K181531: SpineEX Sagittae Lateral Lumbar Interbody Fusion Devices (Oct 5, 2018)

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