K232167

VySpan™ PCT System

510(k) number
K232167
Device name
VySpan™ PCT System
Applicant
Vy Spine, LLC FL · US
Product code
NKG — Posterior Cervical Screw System
Decision date
2023-09-27
Date received
2023-07-21
Decision
Substantially Equivalent
Clearance type
Special
Advisory committee
Orthopedic
510(k) Summary (official FDA PDF): K232167.pdf
Official FDA record: K232167
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.