Mazor Robotics , Ltd.: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Mazor Robotics , Ltd.” (first 2011, latest 2025), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 88 days. Since 2017 the median was 88 days, against 103 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Medtronic, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 118 |
| 2013 | 0 | — |
| 2014 | 1 | 230 |
| 2015 | 1 | 118 |
| 2016 | 0 | — |
| 2017 | 2 | 82 |
| 2018 | 2 | 90 |
| 2019 | 0 | — |
| 2020 | 2 | 28 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 88 |
| 2024 | 0 | — |
| 2025 | 1 | 135 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Mazor Robotics , Ltd. took a median 88 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 103 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OLO | Orthopedic Stereotaxic Instrument | 10 | 10 |
| HAW | Neurological Stereotaxic Instrument | 3 | 3 |
Review panels
- Orthopedic (10)
- Neurology (3)
Most recent Mazor Robotics , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K251316 | Mazor X System / Mazor X Stealth Edition | OLO | 2025-09-11 | 135 |
| K230064 | Mazor X System (Mazor X Stealth Edition) | OLO | 2023-04-07 | 88 |
| K203005 | Mazor X | OLO | 2020-10-27 | 26 |
| K200935 | Mazor X | OLO | 2020-05-08 | 30 |
| K182077 | Mazor X System (Mazor X Stealth Edition) | OLO | 2018-11-02 | 93 |
| K180307 | Mazor X | OLO | 2018-04-30 | 87 |
| K172522 | Mazor X | OLO | 2017-09-15 | 25 |
| K163221 | Mazor X | OLO | 2017-04-04 | 139 |
| K152041 | Renaissance X System | OLO | 2015-11-17 | 118 |
| K140167 | RENAISSANCE X SYSTEM | OLO | 2014-09-10 | 230 |
3 earlier clearances. See the full list in Caduvo.
Recalls
5 product recalls in 5 recall events; 3 initiated in the last five years. Most recent: 2025-12-10.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Mazor Robotics , Ltd. is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT00810433: A Clinical Study of the GO-LIF® Approach for Lumbar Spinal Fixation (Completed, started 2009-02)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Mazor Surgical Technologies , Ltd. (7 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Mazor Robotics , Ltd.?
FDA lists 13 510(k) clearances under the applicant name “Mazor Robotics , Ltd.” (first 2011, latest 2025), across 2 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Mazor Robotics , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Mazor Robotics , Ltd. is 88 days. Since 2017: 88 days, versus 103 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Mazor Robotics , Ltd.?
The most frequent FDA product codes under this applicant name are OLO (Orthopedic Stereotaxic Instrument, 10); HAW (Neurological Stereotaxic Instrument, 3).
Next steps
- See all 13 Mazor Robotics , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code OLO, Mazor Robotics , Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.