Cleared Traditional

V3 Segmental Plating System

K182418 · Atlas Spine, Inc. · Orthopedic
Nov 2018
Decision
85d
Days
Class 2
Risk

About This 510(k) Submission

K182418 is an FDA 510(k) clearance for the V3 Segmental Plating System, a Appliance, Fixation, Spinal Intervertebral Body (Class II — Special Controls, product code KWQ), submitted by Atlas Spine, Inc. (Jupiter, US). The FDA issued a Cleared decision on November 29, 2018, 85 days after receiving the submission on September 5, 2018. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3060.

Submission Details

510(k) Number K182418 FDA.gov
FDA Decision Cleared SESE
Date Received September 05, 2018
Decision Date November 29, 2018
Days to Decision 85 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement

Device Classification

Product Code KWQ — Appliance, Fixation, Spinal Intervertebral Body
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3060

Similar Devices — KWQ Appliance, Fixation, Spinal Intervertebral Body

All 661
ANTERIS Thoracolumbar Plate System
K260015 · SpineCraft · Mar 2026
PathLoc Lumbar Plate System
K251940 · L & K Biomed Co., Ltd. · Mar 2026
Aster
K254182 · Osteonic Co., Ltd. · Feb 2026
Lumbar Spine Truss System - Plating Solution (LSTS-PS)
K253201 · 4Web, Inc. · Feb 2026
aprevo? cervical plating system
K252611 · Carlsmed, Inc. · Dec 2025
Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)
K251965 · Alphatec Spine, Inc. · Aug 2025