The following data is part of a premarket notification filed by Neurostructures, Inc. with the FDA for Belvedere™ Lateral Plating System.
Device ID | K153097 |
510k Number | K153097 |
Device Name: | Belvedere™ Lateral Plating System |
Classification | Appliance, Fixation, Spinal Intervertebral Body |
Applicant | NEUROSTRUCTURES, INC. 16 TECHNOLOGY DR. SUITE 165 Irvine, CA 92618 |
Contact | Moti Altarac |
Correspondent | Kenneth C Maxwell EMPIRICAL TESTING CORPORATION 4628 NORTHPARK DRIVE Colorado Springs, CO 80918 |
Product Code | KWQ |
CFR Regulation Number | 888.3060 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-10-26 |
Decision Date | 2016-07-15 |
Summary: | summary |