Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Mazor Robotics , Ltd. — Predicate Candidate Screening
13 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
88 daysmedian FDA review time
139 days90th percentile
13clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251316 | Mazor X System / Mazor X Stealth Edition | Mazor Robotics , Ltd. | 2025-09-11 | 135 | 0 |
| K230064 | Mazor X System (Mazor X Stealth Edition) | Mazor Robotics , Ltd. | 2023-04-07 | 88 | 2 |
| K203005 | Mazor X | Mazor Robotics , Ltd. | 2020-10-27 | 26 | 1 |
| K200935 | Mazor X | Mazor Robotics , Ltd. | 2020-05-08 | 30 | 0 |
| K182077 | Mazor X System (Mazor X Stealth Edition) | Mazor Robotics , Ltd. | 2018-11-02 | 93 | 1 |
| K180307 | Mazor X | Mazor Robotics , Ltd. | 2018-04-30 | 87 | 0 |
| K172522 | Mazor X | Mazor Robotics , Ltd. | 2017-09-15 | 25 | 0 |
| K163221 | Mazor X | Mazor Robotics , Ltd. | 2017-04-04 | 139 | 0 |
| K152041 | Renaissance X System | Mazor Robotics , Ltd. | 2015-11-17 | 118 | 0 |
| K140167 | RENAISSANCE X SYSTEM | Mazor Robotics , Ltd. | 2014-09-10 | 230 | 0 |
| K120812 | RENAISSANCE | Mazor Robotics , Ltd. | 2012-07-12 | 118 | 0 |
| K113228 | RENAISSANCE SYSTEM | Mazor Robotics , Ltd. | 2011-12-01 | 30 | 0 |
| K110911 | RENAISSANCE SYSTEM | Mazor Robotics , Ltd. | 2011-04-28 | 28 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda