The following data is part of a premarket notification filed by Neurostructures, Inc. with the FDA for Cavetto [max] Cervical Cage System.
Device ID | K201769 |
510k Number | K201769 |
Device Name: | Cavetto [MAX] Cervical Cage System |
Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
Applicant | NeuroStructures, Inc. 199 Technology Drive, Suite 110 Irvine, CA 92618 |
Contact | Moti Altarac |
Correspondent | Nathan Wright 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 | 2020-06-29 |
Decision Date | 2020-09-03 |