Cleared Traditional

Lotus Posterior Cervical/Thoracic Spinal System

K151705 · Spinal Elements, Inc. · Orthopedic

Sep 2015

Decision

71d

Days

Class 2

Risk

About This 510(k) Submission

K151705 is an FDA 510(k) clearance for the Lotus Posterior Cervical/Thoracic Spinal System, a Posterior Cervical Screw System (Class II — Special Controls, product code NKG), submitted by Spinal Elements, Inc. (Carlsbad, US). The FDA issued a Cleared decision on September 3, 2015, 71 days after receiving the submission on June 24, 2015. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3075.

Submission Details

510(k) Number	K151705 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 24, 2015
Decision Date	September 03, 2015
Days to Decision	71 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.