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 |