Globus Medical, Inc. · Class II · Cleared Dec 21, 2017
| K-number | K171848 |
| Device name | FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO Corpectomy Spacers, SUSTAIN Spacers, COALITION Spacers, PATRIOT Lumbar Spacers, PATRIOT Cervical Spacers, ALTERA Spacers, RISE Spacers, CALIBER Spacers, ELSA Spacers, LATIS Spacers, MONUMENT Spacers, InterContinental Plate-Spacer, MAGNIFY Spacers, INDEPENDENCE Spacers |
| Applicant | Globus Medical, Inc. |
| Product code | MAX |
| Device class | Class II |
| Decision date | Dec 21, 2017 |
| Decision | Substantially Equivalent |
| Regulation | 888.3080 |
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