The following data is part of a premarket notification filed by Neurostructures, Inc. with the FDA for Neurostructures Cavetto® Cervical Cage System.
Device ID | K172320 |
510k Number | K172320 |
Device Name: | Neurostructures Cavetto® Cervical Cage System |
Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
Applicant | NeuroStructures, Inc. 16 Technology Drive Suite 165 Irvine, CA 92618 |
Contact | Kathleen Wong |
Correspondent | Kenneth C. Maxwell Ii Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, CO 80918 |
Product Code | ODP |
CFR Regulation Number | 888.3080 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-08-01 |
Decision Date | 2018-02-26 |
Summary: | summary |