FDA.reportPublic FDA data

510(k) K230936

Device
Anatomic PEEK? Cervical Fusion System with Nanotechnology
Applicant
Nanovis, LLC
510(k) number
K230936
Product code
ODP
Decision
Substantially Equivalent (SESE)
Decision date
2023-06-02
Date received
2023-04-03
Regulation
888.3080
Classification name
Intervertebral Fusion Device With Bone Graft, Cervical
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Brian More
Address
5865 E. State Rd. 14 Columbia City IN US 46725 46725

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code ODP#

510(k), Device, Applicant table
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