NEXXT MATRIXX System— 510(k) K193412

Substantially Equivalent

Nexxt Spine, LLC

FDA 510(k) clearance K193412 for NEXXT MATRIXX System, Substantially Equivalent on 2020-02-24. Applicant: Nexxt Spine, LLC. Device class: 2.

Clearance details

Applicant: Nexxt Spine, LLC
Product code: Code PLR
Device class: Class 2
Regulation: 21 CFR 888.3060
Advisory panel: Orthopedic
Date received: 2019-12-09
Decision date: 2020-02-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Noblesville, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code PLR

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 Nexxt Spine, LLC

K231799 — INERTIA® CONNEXX Modular Pedicle Screw System2023-07-20
K221905 — INERTIA CONNEXX Modular Pedicle Screw System2022-07-28
K220291 — NEXXT SPINE NAVIGATION System2022-03-31
K202230 — NEXXT MATRIXX Stand Alone ALIF System2020-12-15
K202192 — STRUXXURE®-L and STRUXXURE®-A Plate System2020-09-17

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