FDA.report

510(k) K223790

Device
Huvex Interspinous Fusion System
Applicant
Dio Medical Corp.
510(k) number
K223790
Product code
PEK
Decision
Substantially Equivalent (SESE)
Decision date
2023-03-09
Date received
2022-12-19
Regulation
888.3050
Classification name
Spinous Process Plate
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Milan George
Address
2100 Campus Ln. Suite 100 East Norriton PA US 19403 19403

FDA Registration Numbers

Source Documents

510(k) summary PDF

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