# Ouroboros Medical

- Location (FDA's records): Fremont, CA
- FDA decisions: 3 (2012–2016): 3 510(k) clearances
- Names in FDA's records: Ouroboros Medical (2); Ouroboros Medical, Inc. (1)
- Product codes: MAX (2), HRX (1)
- Predicates its devices cite: 7 (1 its own); citations of its devices by later devices: 6 (1 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Globus Medical, Inc.: 3 (https://510kreport.com/company/globus-medical)
- Spine Wave, Inc.: 1 (https://510kreport.com/company/spine-wave)
- Hydrocision, Inc.: 1 (https://510kreport.com/company/hydrocision)
- Blackstone Medical, Inc.: 1 (https://510kreport.com/company/blackstone-medical)

## Firms that cite its devices most
- Integrity Implants, Inc.: 4 (https://510kreport.com/company/integrity-implants)
- Medos International SARL: 1 (https://510kreport.com/company/medos-international)

## Its most-cited devices
- K133514: Xcage Interbody Fusion System (2014), cited by 3
- K160076: XCage™ Interbody Fusion System (2016), cited by 2
- K122861: XTOOL (2012), cited by 1

## Recent decisions
- K160076: XCage™ Interbody Fusion System (Oct 13, 2016)
- K133514: Xcage Interbody Fusion System (May 1, 2014)
- K122861: XTOOL (Dec 7, 2012)

Source page: https://510kreport.com/company/ouroboros-medical