The following data is part of a premarket notification filed by Spinal Simplicity Llc with the FDA for Minuteman G5 Mis Fusion Plate.
| Device ID | K211880 |
| 510k Number | K211880 |
| Device Name: | Minuteman G5 MIS Fusion Plate |
| Classification | Spinous Process Plate |
| Applicant | Spinal Simplicity LLC 6600 College Blvd, Ste 220 Overland Park, KS 66211 |
| Contact | Adam Rogers |
| Correspondent | Adam Rogers Spinal Simplicity LLC 6600 College Blvd, Ste 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 | 2021-06-21 |
| Decision Date | 2022-03-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M943100104000 | K211880 | 000 |
| M943100103000 | K211880 | 000 |
| M943100102000 | K211880 | 000 |
| M943100101000 | K211880 | 000 |
| M943100100000 | K211880 | 000 |