FDA.reportPublic FDA data

510(k) K250987

Device
aprevo® posterior/transforaminal lumbar interbody fusion device
Applicant
Carlsmed, Inc.
510(k) number
K250987
Product code
MAX
Decision
Substantially Equivalent (SESE)
Decision date
2025-06-30
Date received
2025-03-31
Regulation
888.3080
Classification name
Intervertebral Fusion Device With Bone Graft, Lumbar
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Jesse Albright
Address
1800 Aston Ave. Suite 100 Carlsbad CA US 92008 92008

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
K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.2026-05-29
K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.2026-05-28
K260506Ventana® P/T Lumbar Interbody SystemSpinal Elements, Inc.2026-05-15
K260837VersaLift Expandable SystemLife Spine, Inc.2026-05-12
K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and transforaminal lumbar interbody system; aprevo® cervical interbody system; corra™ cervical plating systemCarlsmed, Inc.2026-05-09
K261067BEE PLIF CageNGMedical GmbH2026-04-30
K254017SWINGO-3D Lumbar Cage SystemImplanet2026-02-26
K253583LUX Expandable Lumbar Interbody SystemXenix Medical2026-02-23
K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.2026-02-04
K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.2026-01-23
K253266Titanium Interbody SystemSpine Innovation, LLC2026-01-08
K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)2025-12-19
K252610ZSFab Lumbar Interbody SystemZsfab, Inc.2025-11-25
K252351UniSpace® TPLIF CageCg Medtech Co., Ltd.2025-10-28
K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.2025-10-24