NuVasive Anterior Cervical Plate Systems— 510(k) K212446

Name: FDA 510(k) clearance K212446
Creator: U.S. Food and Drug Administration
Published: 2021-11-03

Substantially Equivalent

Nu Vasive, Incorporated

FDA 510(k) clearance K212446 for NuVasive Anterior Cervical Plate Systems, Substantially Equivalent on 2021-11-03. Applicant: Nu Vasive, Incorporated. Device class: 2.

Clearance details

Applicant: Nu Vasive, Incorporated
Product code: Code KWQ
Device class: Class 2
Regulation: 21 CFR 888.3060
Advisory panel: Orthopedic
Date received: 2021-08-05
Decision date: 2021-11-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KWQ

view all

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 Nu Vasive, Incorporated

view all

K231735 — NuVasive CoRoent Small Interbody System +5 more2023-07-11
K230894 — NuVasive Modulus ALIF System2023-06-16
K230989 — Rod Registration Frame2023-05-05
K223181 — NuVasive Reline System2023-01-11
K221751 — NuVasive Cohere ALIF System Intervertebral Body Fusion Device2022-10-21

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.