Stryker VariAx 2 MIS Calcaneus
K-Number: K221346 · 2022-07-08
ApplicantStryker GmbH
Decision Date2022-07-08
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Stryker VariAx 2 MIS Calcaneus is a medical device manufactured by Stryker GmbH. It received FDA 510(k) clearance on 2022-07-08 under approval number K221346. 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 Stryker VariAx 2 MIS Calcaneus?
Stryker VariAx 2 MIS Calcaneus is a medical device that received FDA 510(k) clearance on 2022-07-08. It is manufactured by Stryker GmbH. The 510(k) number is K221346.
When was Stryker VariAx 2 MIS Calcaneus approved by the FDA?
Stryker VariAx 2 MIS Calcaneus received FDA 510(k) clearance on 2022-07-08, under approval number K221346.
What company makes Stryker VariAx 2 MIS Calcaneus?
Stryker VariAx 2 MIS Calcaneus is manufactured by Stryker GmbH.
What is the FDA product code for Stryker VariAx 2 MIS Calcaneus?
The FDA product code for Stryker VariAx 2 MIS Calcaneus 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.