Mazor Surgical Technologies , Ltd.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Mazor Surgical Technologies , Ltd.” (first 2004, latest 2011), across 3 product codes in 3 review panels. Median 510(k) review time under this name: 77 days. 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 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HAW | Neurological Stereotaxic Instrument | 5 | 5 |
| LLZ | System, Image Processing, Radiological | 1 | 1 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 1 | 1 |
Review panels
- Neurology (5)
- Orthopedic (1)
- Radiology (1)
Most recent Mazor Surgical Technologies , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K101446 | EMERALD SPINAL SYSTEM | MNH | 2011-01-20 | 241 |
| K102130 | TENZING SYSTEM | HAW | 2010-08-26 | 28 |
| K081672 | C-INSIGHT | LLZ | 2008-08-15 | 63 |
| K073467 | SPINEASSIST SYSTEM | HAW | 2008-05-23 | 165 |
| K063607 | SPINEASSIST SYSTEM | HAW | 2007-08-23 | 262 |
| K051676 | SPINEASSIST DEVICE WITH ADDITIONAL ACCESSORIES | HAW | 2005-09-08 | 77 |
| K033413 | SPINEASSIST DEVICE | HAW | 2004-01-07 | 72 |
Recalls
openFDA lists no recalls under a recalling firm named Mazor Surgical Technologies , Ltd..
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.
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 Robotics , Ltd. (13 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Mazor Surgical Technologies , Ltd.?
FDA lists 7 510(k) clearances under the applicant name “Mazor Surgical Technologies , Ltd.” (first 2004, latest 2011), across 3 product codes in 3 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 Surgical Technologies , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Mazor Surgical Technologies , Ltd. is 77 days.
Which FDA product codes appear under Mazor Surgical Technologies , Ltd.?
The most frequent FDA product codes under this applicant name are HAW (Neurological Stereotaxic Instrument, 5); LLZ (System, Image Processing, Radiological, 1); MNH (Orthosis, Spondylolisthesis Spinal Fixation, 1).
Next steps
- See all 7 Mazor Surgical Technologies , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code HAW, Mazor Surgical Technologies , 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.