Normandy VBR System— 510(k) K180673

Name: FDA 510(k) clearance K180673
Creator: U.S. Food and Drug Administration
Published: 2018-07-13

Substantially Equivalent

Zavation Medical Products, LLC

FDA 510(k) clearance K180673 for Normandy VBR System, Substantially Equivalent on 2018-07-13. Applicant: Zavation Medical Products, LLC. Device class: 2.

Clearance details

Applicant: Zavation Medical Products, LLC
Product code: Code PLR
Device class: Class 2
Regulation: 21 CFR 888.3060
Advisory panel: Orthopedic
Date received: 2018-03-14
Decision date: 2018-07-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Flowood, MS, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code PLR

view all

K252822 — Atlas Spine HiRISE Expandable Cervical-p Corpectomy Implant2026-07-15
K252560 — Atlas Spine HiRISE Expandable Cervical Corpectomy System2025-11-10
K232481 — RIGEL 3DR Anterior Cervical Corpectomy System2023-10-13
K221542 — Galileo Vertebral Body Replacement Device2023-01-13
K212126 — MediExpand Cervical Expandable VBR System2022-04-04

More clearances from Zavation Medical Products, LLC

view all

K253943 — Tiger 2 System2026-07-24
K243908 — Tiger 2 System2025-02-03
K233509 — Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System, LABYRINTH System, Zavation ALIF System2024-04-10
K231811 — Zavation Connector System2023-08-22
K223808 — Zavation Navigation Instrument System2023-07-12

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