FDA 510(k)

Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal System

K-Number: K192818 · 2020-03-31

Decision Date2020-03-31

Product CodePML

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal System is a medical device manufactured by Stryker Corporation. It received FDA 510(k) clearance on 2020-03-31 under approval number K192818. 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 Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal System?

Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal System is a medical device that received FDA 510(k) clearance on 2020-03-31. It is manufactured by Stryker Corporation. The 510(k) number is K192818.

When was Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal System approved by the FDA?

Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal System received FDA 510(k) clearance on 2020-03-31, under approval number K192818.

What company makes Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal System?

Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal System is manufactured by Stryker Corporation.

What is the FDA product code for Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal System?

The FDA product code for Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal System is PML.

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Related Devices (Code: PML)

K160879CONFIDENCE High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw SystemsMedos International Sàrl K152604KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw SetMedtronic Sofamor Danek USA, Incorporated 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.

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.