FDA.reportPublic FDA data

510(k) K241487

Device
Interwedge® Standalone Lateral
Applicant
Foundation Surgical Group, Inc.
510(k) number
K241487
Product code
OVD
Decision
Substantially Equivalent (SESE)
Decision date
2024-10-02
Date received
2024-05-24
Regulation
888.3080
Classification name
Intervertebral Fusion Device With Integrated Fixation, Lumbar
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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