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FDA 510(k)

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

K-Number: K192818 · 2020-03-31

ApplicantStryker Corporation
Decision Date2020-03-31
Product CodePML
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal System is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Corporation. It received FDA 510(k) clearance on 2020-03-31 under 510(k) 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. The listed applicant is Stryker Corporation. The 510(k) number is K192818.

When did Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal System receive FDA 510(k) clearance?

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

Who is the listed applicant for Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal System?

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

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)

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.

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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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