The following data is part of a premarket notification filed by Spinal Simplicity Llc with the FDA for Ha Minuteman G3 Mis Fusion Plate.
| Device ID | K151741 |
| 510k Number | K151741 |
| Device Name: | HA Minuteman G3 MIS Fusion Plate |
| Classification | Spinous Process Plate |
| Applicant | SPINAL SIMPLICITY LLC 10995 QUIVIRA ROAD Overland Park, KS 66210 |
| Contact | Julie Mckee |
| Correspondent | Janice M. Hogan HOGANS LOVELLS US LLP 1835 MARKET STREET, 29TH FLOOR Philadelphia, PA 19103 |
| Product Code | PEK |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-26 |
| Decision Date | 2015-08-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M94310001701609 | K151741 | 000 |
| M94310001701407 | K151741 | 000 |
| M94310001701205 | K151741 | 000 |
| M94310001701003 | K151741 | 000 |
| M9431000170080A | K151741 | 000 |