Globus Medical, Inc. · Class II · Cleared Feb 22, 2017
| K-number | K152022 |
| Device name | SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION® Spacers, COALITION AGX Spacers, INDEPENDENCE® Spacers, FORTIFY®-R Corpectomy Spacers, FORTIFY® I-R Corpectomy Spacers, XPand®-R Corpectomy Spacers, NIKO® Corpectomy Spacers, MONUMENT Spacers, ALTERA Spacers, MAGNIFY Spacers, InterContinental® Plate-Spacer |
| Applicant | Globus Medical, Inc. |
| Product code | MAX |
| Device class | Class II |
| Decision date | Feb 22, 2017 |
| Decision | Substantially Equivalent |
| Regulation | 888.3080 |
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