The following data is part of a premarket notification filed by Spinal Simplicity Llc with the FDA for Posterior Fusion Plate/ha Posterior Fusion Plate, Minuteman G3 Mis Fusion Plate, Ha Minuteman G3 Mis Fusion Plate, Ha Minuteman G3-r Mis Fusion Plate.
| Device ID | K212781 |
| 510k Number | K212781 |
| Device Name: | Posterior Fusion Plate/HA Posterior Fusion Plate, Minuteman G3 MIS Fusion Plate, HA Minuteman G3 MIS Fusion Plate, HA Minuteman G3-R MIS Fusion Plate |
| Classification | Spinous Process Plate |
| Applicant | Spinal Simplicity LLC 6600 College Blvd, Suite 220 Overland Park, KS 66211 |
| Contact | Adam Rogers |
| Correspondent | Adam Rogers Spinal Simplicity LLC 6600 College Blvd, Suite 220 Overland Park, KS 66211 |
| Product Code | PEK |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-01 |
| Decision Date | 2021-12-15 |