Cleared Traditional

ENNOVATE Spinal System

K162134 · Aesculap Implant Systems, LLC · Orthopedic

Dec 2016

Decision

135d

Days

Class 2

Risk

About This 510(k) Submission

K162134 is an FDA 510(k) clearance for the ENNOVATE Spinal System, a Thoracolumbosacral Pedicle Screw System (Class II — Special Controls, product code NKB), submitted by Aesculap Implant Systems, LLC (Center Valley, US). The FDA issued a Cleared decision on December 14, 2016, 135 days after receiving the submission on August 1, 2016. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K162134 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 01, 2016
Decision Date	December 14, 2016
Days to Decision	135 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.