FDA 510(k)

KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw Set

K-Number: K171938 · 2017-10-23

Decision Date2017-10-23

Product CodePML

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw Set is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic. It received FDA 510(k) clearance on 2017-10-23 under 510(k) number K171938. The device is classified under product code PML. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw Set?

KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw Set is a medical device that received FDA 510(k) clearance on 2017-10-23. The listed applicant is Medtronic. The 510(k) number is K171938.

When did KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw Set receive FDA 510(k) clearance?

KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw Set received FDA 510(k) clearance on 2017-10-23, under 510(k) number K171938.

Who is the listed applicant for KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw Set?

The FDA 510(k) record lists Medtronic as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw Set?

The FDA product code for KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw Set is PML.

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Related Devices (Code: PML)

K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.K252885OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical K241034Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw SystemMedacta International S.A.K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS Posterior Spinal Fixation System with G21 V-STEADY Bone CementUlrich Medical USA K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart K222789VADER® Pedicle System, G21 CementIcotec AG

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.