The following data is part of a premarket notification filed by Neurostructures, Inc. with the FDA for Trifore(tm) Cervical Plating System.
Device ID | K171112 |
510k Number | K171112 |
Device Name: | Trifore(tm) Cervical Plating System |
Classification | Appliance, Fixation, Spinal Intervertebral Body |
Applicant | NeuroStructures, Inc. 16 Technology Drive, Suite 165 Irvine, CA 92618 |
Contact | Kathleen Wong |
Correspondent | Kenneth C. Maxwell 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 | 2017-04-14 |
Decision Date | 2017-06-08 |
Summary: | summary |