The following data is part of a premarket notification filed by Globus Medical Inc. with the FDA for Excelsiusgps Cranial 1.0 Module.
| Device ID | K200047 |
| 510k Number | K200047 |
| Device Name: | ExcelsiusGPS Cranial 1.0 Module |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | Globus Medical Inc. 2560 General Armistead Ave. Audubon, PA 19403 |
| Contact | Jennifer Antonacci |
| Correspondent | Jennifer Antonacci Globus Medical Inc. 2560 General Armistead Ave. Audubon, PA 19403 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-01-09 |
| Decision Date | 2020-07-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00193982302320 | K200047 | 000 |
| 00193982192570 | K200047 | 000 |
| 00193982192563 | K200047 | 000 |
| 00193982192556 | K200047 | 000 |
| 00193982192549 | K200047 | 000 |
| 00193982192532 | K200047 | 000 |
| 00193982192518 | K200047 | 000 |
| 00193982192495 | K200047 | 000 |
| 00193982192488 | K200047 | 000 |
| 00193982192365 | K200047 | 000 |
| 00193982192358 | K200047 | 000 |
| 00193982185220 | K200047 | 000 |
| 00193982192587 | K200047 | 000 |
| 00193982192594 | K200047 | 000 |
| 00193982302269 | K200047 | 000 |
| 00193982302238 | K200047 | 000 |
| 00193982192686 | K200047 | 000 |
| 00193982192679 | K200047 | 000 |
| 00193982192662 | K200047 | 000 |
| 00193982192655 | K200047 | 000 |
| 00193982192648 | K200047 | 000 |
| 00193982192631 | K200047 | 000 |
| 00193982192624 | K200047 | 000 |
| 00193982192617 | K200047 | 000 |
| 00193982192600 | K200047 | 000 |
| 00193982143473 | K200047 | 000 |