FDA.reportPublic FDA data

510(k) K250845

Device
Curiteva Porous PEEK Standalone ALIF System
Applicant
Curiteva, Inc.
510(k) number
K250845
Product code
OVD
Decision
Substantially Equivalent (SESE)
Decision date
2025-06-18
Date received
2025-03-20
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
Eric Linder
Address
25127 Will Mccomb Dr. Tanner AL US 35671 35671

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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510(k), Device, Applicant table
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K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.2025-03-17
K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.2024-12-13
K243191Atlas Spine Lateral Expandable Interbody SystemAtlas Spine, Inc.2024-11-26
K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical2024-10-29