K180307 is an FDA 510(k) clearance for the Mazor X. This device is classified as a Orthopedic Stereotaxic Instrument (Class II - Special Controls, product code OLO).
Submitted by Mazor Robotics , Ltd. (Caesarea, IL). The FDA issued a Cleared decision on April 30, 2018, 87 days after receiving the submission on February 2, 2018.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 882.4560. Stereotaxic Guidance During Orthopedic Surgery Procedures. Indicated For Orthopedic Joint Or Spine Surgery. Neurological Stereotaxic Instruments Are Classified Under Product Code Haw..
| 510(k) Number | K180307 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 02, 2018 |
| Decision Date | April 30, 2018 |
| Days to Decision | 87 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | OLO - Orthopedic Stereotaxic Instrument |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4560 |
| Definition | Stereotaxic Guidance During Orthopedic Surgery Procedures. Indicated For Orthopedic Joint Or Spine Surgery. Neurological Stereotaxic Instruments Are Classified Under Product Code Haw. |