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510(k) K241332

aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar interbody fusion devices with interfixation; aprevo® transforaminal lumbar interbody fusion device by Carlsmed, Inc. — Product Code MAX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 2024
Date Received
May 10, 2024
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.

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  • 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)
  • K241477 — aprevo® anterior lumbar interbody fusion device with interfixation (October 9, 2024)
  • K241328 — aprevo® Anterior and Lateral Lumbar Interbody Fusion device (ALIF/LLIF); aprevo® (August 12, 2024)

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