Cleared Traditional

Ennovate Cervical Spinal and Occiput System

K213871 · Aesculap Implant Systems, LLC · Orthopedic

Jul 2022

Decision

200d

Days

Class 2

Risk

About This 510(k) Submission

K213871 is an FDA 510(k) clearance for the Ennovate Cervical Spinal and Occiput System, a Posterior Cervical Screw System (Class II — Special Controls, product code NKG), submitted by Aesculap Implant Systems, LLC (Center Valley, US). The FDA issued a Cleared decision on July 1, 2022, 200 days after receiving the submission on December 13, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3075.

Submission Details

510(k) Number	K213871 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 13, 2021
Decision Date	July 01, 2022
Days to Decision	200 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	NKG — Posterior Cervical Screw System
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3075
Definition	Posterior Cervical Screw Systems Are Intended For Use In Fusion Procedures Of The Cervical Spine And/or Craniocervical Junction And/or Cervicothoracic Junction For: 1) Spinal Fractures And Dislocations; 2) Deformities; 3) Instabilities; 4) Failed Previous Fusions; 5) Tumors; 6) Inflammatory Disorders; 7) Spinal Degeneration, 8) Facet Degeneration With Instability; And 9) Reconstruction Following Decompression To Treat Radiculopathy And/or Myelopathy. These Systems Are Also Intended To Stabilize The Spine In The Absence Of Fusion For A Limited Time Period In Patients With Tumors Involving The Cervical Spine In Whom Life Expectancy Is Of Insufficient Duration To Permit Achievement Of Fusion.