The following data is part of a premarket notification filed by Globus Medical Inc. with the FDA for Aqrate Robotic Assistance System.
| Device ID | K182000 |
| 510k Number | K182000 |
| Device Name: | AQrate Robotic Assistance System |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | Globus Medical Inc. 2560 General Armistead Avenue Audubon, PA 19403 |
| Contact | Kelly J. Baker |
| Correspondent | Kelly J. Baker Globus Medical Inc. 2560 General Armistead Avenue Audubon, PA 19403 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-26 |
| Decision Date | 2019-01-29 |
| Summary: | summary |