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FDA 510(k)

Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw Set

K-Number: K191148 · 2019-09-12

ApplicantMedtronic Sofamor Danek USA, Inc.
Decision Date2019-09-12
Product CodePML
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Medtronic HV-R™ Bone Cement, 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 Sofamor Danek USA, Inc.. It received FDA 510(k) clearance on 2019-09-12 under 510(k) number K191148. 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 Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw Set?

Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw Set is a medical device that received FDA 510(k) clearance on 2019-09-12. The listed applicant is Medtronic Sofamor Danek USA, Inc.. The 510(k) number is K191148.

When did Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw Set receive FDA 510(k) clearance?

Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw Set received FDA 510(k) clearance on 2019-09-12, under 510(k) number K191148.

Who is the listed applicant for Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw Set?

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

What is the FDA product code for Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw Set?

The FDA product code for Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw Set is PML.

Other records listing Medtronic Sofamor Danek USA, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

PMA P000058Filler, recombinant human bone morphogenetic protein, collagen scaffold with metal prosthesis, osteoinductionPMA P000054Filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinductionK253011Catalyft PL Expandable Interbody SystemK261020Symmetrix™ L Spinal SystemK253656OsteoCool™ RF Ablation System; OsteoCool™ 2.0 RF Ablation SystemK260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal System

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Related Devices (Code: PML)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.K252885OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura MedicalK241034Meta+ 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 USAK230774PERLA® TL System; TEKTONA® HV US Bone CementSpineartK222789VADER® 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.

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