The following data is part of a premarket notification filed by Globus Medical Inc. with the FDA for Creo Stabilization System, Navigation Instruments, Excelsiusgps.
| Device ID | K203153 |
| 510k Number | K203153 |
| Device Name: | CREO Stabilization System, Navigation Instruments, ExcelsiusGPS |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | Globus Medical Inc. 2560 General Armstead Ave. Audubon, PA 19403 |
| Contact | Jennifer Antonacci |
| Correspondent | Jennifer Antonacci Globus Medical Inc. 2560 General Armstead Ave. Audubon, PA 19403 |
| Product Code | NKB |
| Subsequent Product Code | KWP |
| Subsequent Product Code | OLO |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-10-22 |
| Decision Date | 2021-01-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00193982451202 | K203153 | 000 |
| 00193982452049 | K203153 | 000 |
| 00193982452063 | K203153 | 000 |
| 00193982452384 | K203153 | 000 |
| 00193982452407 | K203153 | 000 |
| 00193982452421 | K203153 | 000 |
| 00193982452445 | K203153 | 000 |
| 00193982452766 | K203153 | 000 |
| 00193982452780 | K203153 | 000 |
| 00193982452025 | K203153 | 000 |
| 00193982452001 | K203153 | 000 |
| 00193982451226 | K203153 | 000 |
| 00193982451240 | K203153 | 000 |
| 00193982451264 | K203153 | 000 |
| 00193982451608 | K203153 | 000 |
| 00193982451622 | K203153 | 000 |
| 00193982451646 | K203153 | 000 |
| 00193982451660 | K203153 | 000 |
| 00193982451981 | K203153 | 000 |
| 00193982452803 | K203153 | 000 |
| 00193982452827 | K203153 | 000 |
| 00193982452841 | K203153 | 000 |
| 00193982299767 | K203153 | 000 |
| 00193982299774 | K203153 | 000 |
| 00193982299781 | K203153 | 000 |
| 00193982299798 | K203153 | 000 |
| 00193982299941 | K203153 | 000 |
| 00193982299958 | K203153 | 000 |
| 00193982299965 | K203153 | 000 |
| 00193982299972 | K203153 | 000 |
| 00193982299750 | K203153 | 000 |
| 00193982299590 | K203153 | 000 |
| 00193982453145 | K203153 | 000 |
| 00193982453169 | K203153 | 000 |
| 00193982453183 | K203153 | 000 |
| 00193982453206 | K203153 | 000 |
| 00193982453220 | K203153 | 000 |
| 00193982299569 | K203153 | 000 |
| 00193982299576 | K203153 | 000 |
| 00193982299583 | K203153 | 000 |
| 00193982299989 | K203153 | 000 |