Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Mazor Surgical Technologies , Ltd. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
77 daysmedian FDA review time
262 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K101446 | EMERALD SPINAL SYSTEM | Mazor Surgical Technologies , Ltd. | 2011-01-20 | 241 | 0 |
| K102130 | TENZING SYSTEM | Mazor Surgical Technologies , Ltd. | 2010-08-26 | 28 | 0 |
| K081672 | C-INSIGHT | Mazor Surgical Technologies , Ltd. | 2008-08-15 | 63 | 0 |
| K073467 | SPINEASSIST SYSTEM | Mazor Surgical Technologies , Ltd. | 2008-05-23 | 165 | 0 |
| K063607 | SPINEASSIST SYSTEM | Mazor Surgical Technologies , Ltd. | 2007-08-23 | 262 | 0 |
| K051676 | SPINEASSIST DEVICE WITH ADDITIONAL ACCESSORIES | Mazor Surgical Technologies , Ltd. | 2005-09-08 | 77 | 0 |
| K033413 | SPINEASSIST DEVICE | Mazor Surgical Technologies , Ltd. | 2004-01-07 | 72 | 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