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510(k) K241477

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 9, 2024
Date Received
May 24, 2024
Clearance Type
Traditional
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.

  • K252894 — aprevo® cervical interbody system (January 6, 2026)
  • K252611 — aprevo® cervical plating system (December 22, 2025)
  • 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)
  • K243635 — aprevo® anterior lumbar interbody fusion device with interfixation (December 13, 2024)
  • K242260 — aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAM (November 15, 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)

Other clearances for product code OVD

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  • K250072 — CONDUIT™ SYNFIX™ Evolution Secured Spacer System (July 10, 2025)
  • K251644 — ProAM ALIF System (June 24, 2025)
  • K250845 — Curiteva Porous PEEK Standalone ALIF System (June 18, 2025)
  • K251459 — OneLIF™ Interbody Fusion System (June 12, 2025)
  • K243934 — Stable-L Lumbar Interbody System (April 30, 2025)
  • K243386 — Ventris Intervertebral Body Fusion Device (April 22, 2025)
  • K250603 — AxTiHA® Stand-Alone ALIF System (March 24, 2025)