K182000 is an FDA 510(k) clearance for the AQrate Robotic Assistance System. This device is classified as a Neurological Stereotaxic Instrument (Class II - Special Controls, product code HAW).
Submitted by Globus Medical, Inc. (Audubon, US). The FDA issued a Cleared decision on January 29, 2019, 187 days after receiving the submission on July 26, 2018.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 882.4560.
| 510(k) Number | K182000 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 26, 2018 |
| Decision Date | January 29, 2019 |
| Days to Decision | 187 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | HAW — Neurological Stereotaxic Instrument |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4560 |