Cleared Traditional

CD Horizon? Fenestrated Screw Set, CD Horizon? Spinal System, Kyphon? HV-R? Bone Cement

K201362 · Medtronic · Orthopedic

Aug 2020

Decision

89d

Days

Class 2

Risk

About This 510(k) Submission

K201362 is an FDA 510(k) clearance for the CD Horizon? Fenestrated Screw Set, CD Horizon? Spinal System, Kyphon? HV-R? Bone Cement, a Bone Cement, Posterior Screw Augmentation (Class II — Special Controls, product code PML), submitted by Medtronic (Memphis, US). The FDA issued a Cleared decision on August 19, 2020, 89 days after receiving the submission on May 22, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3027.

Submission Details

510(k) Number	K201362 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 22, 2020
Decision Date	August 19, 2020
Days to Decision	89 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	PML — Bone Cement, Posterior Screw Augmentation
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3027
Definition	The Device Is Intended To Augment The Fixation Of Screws In A Posterior Spinal System Construct.