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510(k) K250827

aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion device; aprevo® anterior lumbar interbody fusion device with interfixation; aprevo® transforaminal lumbar interbody fusion device; aprevo® TLIF-CA Articulating System; aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X No Cams by Carlsmed, Inc. — Product Code MAX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 7, 2025
Date Received
March 18, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Intervertebral Fusion Device With Bone Graft, Lumbar
Device Class
Class II
Regulation Number
888.3080
Review Panel
OR
Submission Type

Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.

Other clearances by Carlsmed, Inc.

  • K252894 — aprevo® cervical interbody system (January 6, 2026)
  • K252611 — aprevo® cervical plating system (December 22, 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)
  • 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)

Other clearances for product code MAX

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  • K253748 — Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spac (January 23, 2026)
  • K253266 — Titanium Interbody System (January 8, 2026)
  • K253577 — IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter) (December 19, 2025)
  • K252610 — ZSFab Lumbar Interbody System (November 25, 2025)
  • K252351 — UniSpace® TPLIF Cage (October 28, 2025)
  • K253377 — Expandable Titanium PLIF/TLIF System (October 24, 2025)
  • K251479 — Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion C (September 18, 2025)