Cleared Traditional

Spinal Elements Cerclage System

K180728 · Spinal Elements, Inc. · Orthopedic

Sep 2018

Decision

170d

Days

Class 2

Risk

About This 510(k) Submission

K180728 is an FDA 510(k) clearance for the Spinal Elements Cerclage System, a Bone Fixation Cerclage, Sublaminar (Class II — Special Controls, product code OWI), submitted by Spinal Elements, Inc. (Carlsbad, US). The FDA issued a Cleared decision on September 6, 2018, 170 days after receiving the submission on March 20, 2018. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3010.

Submission Details

510(k) Number	K180728 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 20, 2018
Decision Date	September 06, 2018
Days to Decision	170 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	OWI — Bone Fixation Cerclage, Sublaminar
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3010
Definition	Acts As A Bone Anchor For Temporary Stabilization, Or Used In Conjunction With Other Medical Implants Of Similar Metals When Wiring Is Needed, During Development Of A Spinal Fusion.