The following data is part of a premarket notification filed by Neurostructures, Inc. with the FDA for Cavetto-sa Cervical Cage System.
Device ID | K173077 |
510k Number | K173077 |
Device Name: | Cavetto-SA Cervical Cage System |
Classification | Intervertebral Fusion Device With Integrated Fixation, 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 | OVE |
CFR Regulation Number | 888.3080 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-09-29 |
Decision Date | 2018-02-23 |
Summary: | summary |