Curiteva Midline Anterior Cervical Plate System (or Curiteva Anterior Cervical Plate System)— 510(k) K181549

Name: FDA 510(k) clearance K181549
Creator: U.S. Food and Drug Administration
Published: 2018-08-03

Substantially Equivalent

Curiteva, LLC

FDA 510(k) clearance K181549 for Curiteva Midline Anterior Cervical Plate System (or Curiteva Anterior Cervical Plate System), Substantially Equivalent on 2018-08-03. Applicant: Curiteva, LLC. Device class: 2.

Clearance details

Applicant: Curiteva, LLC
Product code: Code KWQ
Device class: Class 2
Regulation: 21 CFR 888.3060
Advisory panel: Orthopedic
Date received: 2018-06-12
Decision date: 2018-08-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tanner, AL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KWQ

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K261309 — Palisades Buttress Plate System2026-07-16
K252776 — ARIES Anterior Cervical Plate Systems2026-05-14
K261112 — CastleLoc-P Anterior Cervical Plate System2026-05-06
K260570 — corra cervical plating system2026-04-22
K260697 — VyPlate Anterior Cervical Plate System2026-03-27

More clearances from Curiteva, LLC

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K181589 — Curiteva Lumbar Interbody Fusion System2018-12-20
K181562 — Curiteva Anterior Cervical Plate System2018-08-02
K181261 — Curiteva Cervical Interbody Fusion System2018-07-09

Adverse events under product code KWQ

product code KWQ

Death: 8
Injury: 1,212
Malfunction: 1,233
Total: 2,453

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.