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 |