The following data is part of a premarket notification filed by Neurostructures, Inc. with the FDA for Neurostructures Cavetto® [max] Cervical Cage System.
Device ID | K181590 |
510k Number | K181590 |
Device Name: | Neurostructures 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 | Kathleen Wong |
Correspondent | Meredith Lee May Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, CO 80918 |
Product Code | ODP |
CFR Regulation Number | 888.3080 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-06-18 |
Decision Date | 2018-11-08 |
Summary: | summary |