Curiteva Laminoplasty System— 510(k) K231232

Substantially Equivalent

Curiteva, Inc.

FDA 510(k) clearance K231232 for Curiteva Laminoplasty System, Substantially Equivalent on 2023-06-28. 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: 2023-04-28
Decision date: 2023-06-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tanner, AL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code NQW

K252930 — AQUA Laminoplasty Systems2026-05-27
K243137 — Curiteva Porous PEEK Laminoplasty System2024-10-28
K242784 — Vy Spine VyLam Laminoplasty System2024-10-16
K232471 — Vy Spine VyLam Laminoplasty System2023-10-10
K212428 — Centerpiece Plate Fixation System2021-12-13

More clearances from Curiteva, Inc.

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
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.