Cleared Traditional

Mercury? Spinal System, Overwatch? Spinal System

K191576 · Spinal Elements, Inc. · Orthopedic

Sep 2019

Decision

94d

Days

Class 2

Risk

About This 510(k) Submission

K191576 is an FDA 510(k) clearance for the Mercury? Spinal System, Overwatch? Spinal System, a Thoracolumbosacral Pedicle Screw System (Class II — Special Controls, product code NKB), submitted by Spinal Elements, Inc. (Carlsbad, US). The FDA issued a Cleared decision on September 16, 2019, 94 days after receiving the submission on June 14, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K191576 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 14, 2019
Decision Date	September 16, 2019
Days to Decision	94 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	NKB — Thoracolumbosacral Pedicle Screw System
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3070
Definition	Intended To Provide Immobilization And Stabilization Of Spinal Segments In Thoracic, Lumbar, And Sacral Spine As An Adjunct To Fusion.