Curiteva Porous PEEK Laminoplasty System— 510(k) K243137

Name: FDA 510(k) clearance K243137
Creator: U.S. Food and Drug Administration
Published: 2024-10-28

Substantially Equivalent

Curiteva, Inc.

FDA 510(k) clearance K243137 for Curiteva Porous PEEK Laminoplasty System, Substantially Equivalent on 2024-10-28. Applicant: Curiteva, Inc.. Device class: 2.

Clearance details

Applicant: Curiteva, Inc.
Product code: Code NQW
Device class: Class 2
Regulation: 21 CFR 888.3050
Advisory panel: Orthopedic
Date received: 2024-09-30
Decision date: 2024-10-28
Decision: Substantially Equivalent
Clearance type: Special
Location: Tanner, AL, US

Download summary PDF View on FDA.gov ↗

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K212428 — Centerpiece Plate Fixation System2021-12-13

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K233360 — Curiteva Thoracolumbar Plate System2024-02-29
K233744 — Curiteva Porous PEEK Lumbar Interbody Fusion System2024-01-18

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