Cleared Traditional

KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw Set

K171938 · Medtronic · Orthopedic

Oct 2017

Decision

117d

Days

Class 2

Risk

About This 510(k) Submission

K171938 is an FDA 510(k) clearance for the KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw Set, 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 October 23, 2017, 117 days after receiving the submission on June 28, 2017. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3027.

Submission Details

510(k) Number	K171938 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 28, 2017
Decision Date	October 23, 2017
Days to Decision	117 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.