aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal lumbar interbody fusion devices— 510(k) K222082

Name: FDA 510(k) clearance K222082
Creator: U.S. Food and Drug Administration
Published: 2022-08-12

Substantially Equivalent

Carlsmed, Inc.

FDA 510(k) clearance K222082 for aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal lumbar interbody fusion devices, Substantially Equivalent on 2022-08-12. Applicant: Carlsmed, Inc.. Device class: 2.

Clearance details

Applicant: Carlsmed, Inc.
Product code: Code MAX
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2022-07-15
Decision date: 2022-08-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Carlsbad, CA, US

Download summary PDF View on FDA.gov ↗

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K261020 — Symmetrix L Spinal System2026-07-14
K253420 — Admiral ACP System +18 more2026-07-01

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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.