510(k) K243635

aprevo® anterior lumbar interbody fusion device with interfixation by Carlsmed, Inc. — Product Code OVD

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: December 13, 2024
Date Received: November 25, 2024
Clearance Type: Special
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Intervertebral Fusion Device With Integrated Fixation, Lumbar
Device Class: Class II
Regulation Number: 888.3080
Review Panel: OR
Submission Type

Intended to stabilize lumbar spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation.

Other clearances by Carlsmed, Inc.

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K250827 — aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbod (July 7, 2025)
K250987 — aprevo® posterior/transforaminal lumbar interbody fusion device (June 30, 2025)
K243802 — aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lu (March 17, 2025)
K242599 — aprevo® Digital Planning (December 20, 2024)
K242260 — aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAM (November 15, 2024)
K241477 — aprevo® anterior lumbar interbody fusion device with interfixation (October 9, 2024)
K241332 — aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lu (September 20, 2024)
K241328 — aprevo® Anterior and Lateral Lumbar Interbody Fusion device (ALIF/LLIF); aprevo® (August 12, 2024)

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