The following data is part of a premarket notification filed by Spinal Simplicity with the FDA for Ha Minuteman G3-r Mis Fusion Plate.
| Device ID | K163428 |
| 510k Number | K163428 |
| Device Name: | HA Minuteman G3-R MIS Fusion Plate |
| Classification | Spinous Process Plate |
| Applicant | Spinal Simplicity 10995 Quivira Road Overland Park, KS 66210 |
| Contact | Douglas B Snell |
| Correspondent | Douglas B Snell Spinal Simplicity 10995 Quivira Road Overland Park, KS 66210 |
| Product Code | PEK |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-06 |
| Decision Date | 2017-02-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M9431000220000 | K163428 | 000 |
| M9431000210000 | K163428 | 000 |
| M9431000200000 | K163428 | 000 |
| M9431000190000 | K163428 | 000 |
| M9431000180000 | K163428 | 000 |