Cleared Traditional

LigaPASS? Spinal System, CD Horizon? Spinal System

K211057 · Medtronic, Inc. · Orthopedic

May 2021

Decision

48d

Days

Class 2

Risk

About This 510(k) Submission

K211057 is an FDA 510(k) clearance for the LigaPASS? Spinal System, CD Horizon? Spinal System, a Bone Fixation Cerclage, Sublaminar (Class II — Special Controls, product code OWI), submitted by Medtronic, Inc. (Memphis, US). The FDA issued a Cleared decision on May 27, 2021, 48 days after receiving the submission on April 9, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3010.

Submission Details

510(k) Number	K211057 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 09, 2021
Decision Date	May 27, 2021
Days to Decision	48 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.