The following data is part of a premarket notification filed by Aurora Spine, Inc. with the FDA for Zip™ Mis Interspinous Fusion System.
| Device ID | K221399 |
| 510k Number | K221399 |
| Device Name: | ZIP™ MIS Interspinous Fusion System |
| Classification | Spinous Process Plate |
| Applicant | Aurora Spine, Inc. 1930 Palomar Point Way, Suite #103 Carlsbad, CA 92008 |
| Contact | Laszlo Garamszegi |
| Correspondent | Justin Eggleton MCRA LLC 803 7th Street NW Washington DC, DC 20001 |
| Product Code | PEK |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-05-13 |
| Decision Date | 2022-07-08 |