Curiteva Porous PEEK Lumbar Interbody Fusion System— 510(k) K233744

Name: FDA 510(k) clearance K233744
Creator: U.S. Food and Drug Administration
Published: 2024-01-18

Substantially Equivalent

Curiteva, Inc.

FDA 510(k) clearance K233744 for Curiteva Porous PEEK Lumbar Interbody Fusion System, Substantially Equivalent on 2024-01-18. Applicant: Curiteva, Inc.. Device class: 2.

Clearance details

Applicant: Curiteva, Inc.
Product code: Code MAX
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2023-11-22
Decision date: 2024-01-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tanner, AL, 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

More clearances from Curiteva, Inc.

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K252205 — Curiteva Porous PEEK Cervical Interbody System +3 more2026-01-16
K254061 — Curiteva Porous PEEK Cervical Interbody Fusion System2026-01-15
K250845 — Curiteva Porous PEEK Standalone ALIF System2025-06-18
K243137 — Curiteva Porous PEEK Laminoplasty System2024-10-28
K233360 — Curiteva Thoracolumbar Plate System2024-02-29

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.