aprevo® anterior and lateral lumbar interbody fusion device +2 more— 510(k) K241332

Name: FDA 510(k) clearance K241332
Creator: U.S. Food and Drug Administration
Published: 2024-09-20

Substantially Equivalent

Carlsmed, Inc.

FDA 510(k) clearance K241332 for aprevo® anterior and lateral lumbar interbody fusion device +2 more, Substantially Equivalent on 2024-09-20. Applicant: Carlsmed, Inc.. Device class: 2.

Clearance details

Device name as filed: aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar interbody fusion devices with interfixation; aprevo® transforaminal lumbar interbody fusion device
Applicant: Carlsmed, Inc.
Product code: Code MAX
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2024-05-10
Decision date: 2024-09-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbad, CA, US

Download summary PDF View on FDA.gov ↗

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K253011 — Catalyft PL Expandable Interbody System2026-07-17
K261020 — Symmetrix L Spinal System2026-07-14
K253420 — Admiral ACP System +18 more2026-07-01

More clearances from Carlsmed, Inc.

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K260385 — aprevo® anterior and lateral lumbar interbody system +3 more2026-05-09
K260570 — corra cervical plating system2026-04-22
K252894 — aprevo® cervical interbody system2026-01-06
K252611 — aprevo® cervical plating system2025-12-22
K250827 — aprevo® anterior lumbar interbody fusion device +7 more2025-07-07

Adverse events under product code MAX

product code MAX

Death: 13
Injury: 1,305
Malfunction: 2,885
Total: 4,203

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.