510(k) K182077 ยท OLO Orthopedic Stereotaxic Instrument
Mazor X System (Mazor X Stealth Edition)
| Applicant | Mazor Robotics , Ltd., Caesarea, IL |
| Decision | Substantially Equivalent, Nov 2, 2018 |
| Received | Aug 1, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182077
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 9, 2020 | Medtronic Navigation, Inc. Mazor X Surgical System Positioner Type II, REF: ASM0214-02 Open, Classified |
OLO | None listed |
| Jul 2, 2019 | Mazor Robotics Ltd Snapshot Tracker Kit, Mas2659-01, KIT0898, Rx Only, Non Sterile, UDI: 07290109181868 Terminated |
OLO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.