FDA.reportPublic FDA data

510(k) K223146

Device
EVOLUTION SPINE Interbody System
Applicant
Evolution Spine
510(k) number
K223146
Product code
OVD
Decision
Substantially Equivalent (SESE)
Decision date
2023-02-07
Date received
2022-10-05
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
Todd Wallenstein
Address
2300 N. Haskell Ave. Dallas TX US 75204 75204

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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510(k), Device, Applicant table
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K251644ProAM ALIF SystemPro Surgical, Inc.2025-06-24
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K251459OneLIF™ Interbody Fusion SystemNovapproach Spine, LLC2025-06-12
K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC2025-04-30