VariAx Foot
K-Number: K192675 · 2019-11-22
ApplicantStryker GmbH
Decision Date2019-11-22
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
VariAx Foot is a medical device manufactured by Stryker GmbH. It received FDA 510(k) clearance on 2019-11-22 under approval number K192675. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the VariAx Foot?
VariAx Foot is a medical device that received FDA 510(k) clearance on 2019-11-22. It is manufactured by Stryker GmbH. The 510(k) number is K192675.
When was VariAx Foot approved by the FDA?
VariAx Foot received FDA 510(k) clearance on 2019-11-22, under approval number K192675.
What company makes VariAx Foot?
VariAx Foot is manufactured by Stryker GmbH.
What is the FDA product code for VariAx Foot?
The FDA product code for VariAx Foot is HRS.
Other Devices by Stryker GmbH
Related Devices (Code: HRS)
K163086VLP MINI-MOD 2.0mm Column PlatesSmith & Nephew, Inc.
K162829Medline UNITE® Ankle Fracture Plating SystemMedline Industries, Inc.
K162974Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation
K163007Biomet Microfixation SternaLock 360 Sternal Closure SystemBiomet Microfixation
K161696aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5Aap Implantate AG
K161747LOQTEQ® VA Distal Tibia Plate System: LOQTEQ® VA Distal Medial Tibia Plate 3.5; LOQTEQ® VA Distal Anterolateral Tibia Plate 3.5; LOQTEQ® VA Distal Fibula Plate 2.7/3.5Aap Implantate 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.