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510(k) K241019

aprevo® TLIF-C Articulating System by Carlsmed — Product Code MAX

K241019 is an FDA 510(k) premarket notification submitted by Carlsmed for the device "aprevo® TLIF-C Articulating System". The FDA issued a decision of Substantially Equivalent on July 9, 2024. The device falls under product code MAX (Intervertebral Fusion Device With Bone Graft, Lumbar), a Class II device regulated under 21 CFR 888.3080. Carlsmed has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 9, 2024
Date Received
April 15, 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

  • K260385 — aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and tran (May 9, 2026)
  • K260570 — corra™ cervical plating system (April 22, 2026)
  • 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)

Other clearances for product code MAX

  • K253011 — Catalyft PL Expandable Interbody System (July 17, 2026)
  • K261020 — Symmetrix™ L Spinal System (July 14, 2026)
  • K253420 — Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Space (July 1, 2026)
  • K253151 — Fule Interbody Fusion Cage System (June 15, 2026)
  • K261159 — Exceed® Biplanar Expandable Interbody System (May 29, 2026)
  • K253894 — BMD Titanium Spinal Fusion System (May 28, 2026)
  • K260506 — Ventana® P/T Lumbar Interbody System (May 15, 2026)
  • K260837 — VersaLift Expandable System (May 12, 2026)
  • K260385 — aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and tran (May 9, 2026)
  • K261067 — BEE PLIF Cage (April 30, 2026)

FDA data resources