NuVasive® VersaTie® System— 510(k) K190418

Name: FDA 510(k) clearance K190418
Creator: U.S. Food and Drug Administration
Published: 2019-03-21

Substantially Equivalent

Nu Vasive, Incorporated

FDA 510(k) clearance K190418 for NuVasive® VersaTie® System, Substantially Equivalent on 2019-03-21. Applicant: Nu Vasive, Incorporated. Device class: 2.

Clearance details

Applicant: Nu Vasive, Incorporated
Product code: Code OWI
Device class: Class 2
Regulation: 21 CFR 888.3010
Advisory panel: Orthopedic
Date received: 2019-02-21
Decision date: 2019-03-21
Decision: Substantially Equivalent
Clearance type: Special
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OWI

view all

K261374 — LigaPASS System2026-05-27
K253615 — Invictus Bands System2026-03-25
K222097 — OLYMPIC Deformity Band System2023-05-04
K230565 — HILINE Fixation System2023-04-20
K213659 — LigaPASS 2.0 Ligament Augmentation System2022-05-24

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

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