The following data is part of a premarket notification filed by Neurostructures, Inc. with the FDA for Transept Cervical Plate System.
Device ID | K200927 |
510k Number | K200927 |
Device Name: | Transept Cervical Plate System |
Classification | Appliance, Fixation, Spinal Intervertebral Body |
Applicant | Neurostructures, Inc. 199 Technology Dr. Suite 110 Irvine, CA 92618 |
Contact | Moti Altarac |
Correspondent | Nathan Wright Empirical Testing Corp. 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 | 2020-04-07 |
Decision Date | 2020-07-24 |