FDA.reportPublic FDA data

510(k) K242457

Device
EARP Interbody System
Applicant
Retropsoas Technologies, LLC
510(k) number
K242457
Product code
MAX
Decision
Substantially Equivalent (SESE)
Decision date
2024-10-07
Date received
2024-08-19
Regulation
888.3080
Classification name
Intervertebral Fusion Device With Bone Graft, Lumbar
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Nicholas Poulos
Address
34 Countryside Ln. Frontenac MO US 63131 63131

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MAX#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
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K253583LUX Expandable Lumbar Interbody SystemXenix Medical2026-02-23
K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.2026-02-04