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FDA 510(k)

KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set

K-Number: K152604 · 2016-01-06

ApplicantMedtronic Sofamor Danek USA, Incorporated
Decision Date2016-01-06
Product CodePML
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set is a medical device manufactured by Medtronic Sofamor Danek USA, Incorporated. It received FDA 510(k) clearance on 2016-01-06 under approval number K152604. 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 HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set?

KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set is a medical device that received FDA 510(k) clearance on 2016-01-06. It is manufactured by Medtronic Sofamor Danek USA, Incorporated. The 510(k) number is K152604.

When was KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set approved by the FDA?

KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set received FDA 510(k) clearance on 2016-01-06, under approval number K152604.

What company makes KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set?

KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set is manufactured by Medtronic Sofamor Danek USA, Incorporated.

What is the FDA product code for KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set?

The FDA product code for KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set is PML.

Related Devices (Code: PML)

K160879CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw SystemsMedos International Sàrl K171938KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw SetMedtronic K180498NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated K172269FORTRESS™ Radiopaque Bone Cement (FORTRESS™ and FORTRESS-Plus™), CREO® Fenestrated Screw System, REVLOK® Fenestrated Screw SystemGlobus Medical, Inc. K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics , Ltd. K191148Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.

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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