FDA.reportPublic FDA data

510(k) K241468

Device
Vertiwedge® Intraosseous System
Applicant
Foundation Surgical Group, Inc.
510(k) number
K241468
Product code
MQP
Decision
Substantially Equivalent (SESE)
Decision date
2024-11-07
Date received
2024-05-24
Regulation
888.3060
Classification name
Spinal Vertebral Body Replacement Device
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Asher Breverman
Address
7327 E Tierra Buena Ln. Suite 101 Scottsdale AZ US 85260 85260

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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