# Mazor Robotics, Ltd.

- Location (FDA's records): Caesarea, IL
- FDA decisions: 13 (2011–2025): 13 510(k) clearances
- Product codes: OLO (10), HAW (3)
- 510(k) review time since 2016: median 88 days, against 91 for FDA's reviews in the same codes and years (6 of 8 faster)
- Predicates its devices cite: 23 (14 its own); citations of its devices by later devices: 17 (14 its own)
- Recalls linked to its devices: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Medtronic Surgical Navigation Technologies: 3 (https://510kreport.com/company/medtronic-surgical-navigation-technologies)
- Medtronic Navigation, Inc.: 2 (https://510kreport.com/company/medtronic-navigation)
- Mazor Surgical Technologies, Ltd.: 1 (https://510kreport.com/company/mazor-surgical-technologies)
- Medtech S.A.S: 1 (https://510kreport.com/company/medtech)
- Medtech S.A: 1 (https://510kreport.com/company/medtech-s-a)
- Nemaris, Inc.: 1 (https://510kreport.com/company/nemaris)

## Firms that cite its devices most
- Medtronic Navigation, Inc.: 1 (https://510kreport.com/company/medtronic-navigation)
- Medtronic Sofamor Danek: 1 (https://510kreport.com/company/medtronic-sofamor-danek)
- Medtronic Sofamor Danek USA, Inc.: 1 (https://510kreport.com/company/medtronic-sofamor-danek-usa)

## Its most-cited devices
- K113228: Renaissance System (2011), cited by 2
- K230064: Mazor X System (Mazor X Stealth Edition) (2023), cited by 2
- K110911: Renaissance System (2011), cited by 2
- K203005: Mazor X (2020), cited by 2
- K163221: Mazor X (2017), cited by 2
- K120812: Renaissance (2012), cited by 1

## Recent decisions
- K251316: Mazor X System / Mazor X Stealth Edition (Sep 11, 2025)
- K230064: Mazor X System (Mazor X Stealth Edition) (Apr 7, 2023)
- K203005: Mazor X (Oct 27, 2020)
- K200935: Mazor X (May 8, 2020)
- K182077: Mazor X System (Mazor X Stealth Edition) (Nov 2, 2018)
- K180307: Mazor X (Apr 30, 2018)
- K172522: Mazor X (Sep 15, 2017)
- K163221: Mazor X (Apr 4, 2017)

Source page: https://510kreport.com/company/mazor-robotics