Triathlon® Hinge Knee System
K-Number: K223528 · 2023-01-20
Decision Date2023-01-20
Product CodeKRO
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Triathlon® Hinge Knee System is a medical device manufactured by Howmedica Osteonics Corp., Dba Stryker Orthopaedics. It received FDA 510(k) clearance on 2023-01-20 under approval number K223528. The device is classified under product code KRO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Triathlon® Hinge Knee System?
Triathlon® Hinge Knee System is a medical device that received FDA 510(k) clearance on 2023-01-20. It is manufactured by Howmedica Osteonics Corp., Dba Stryker Orthopaedics. The 510(k) number is K223528.
When was Triathlon® Hinge Knee System approved by the FDA?
Triathlon® Hinge Knee System received FDA 510(k) clearance on 2023-01-20, under approval number K223528.
What company makes Triathlon® Hinge Knee System?
Triathlon® Hinge Knee System is manufactured by Howmedica Osteonics Corp., Dba Stryker Orthopaedics.
What is the FDA product code for Triathlon® Hinge Knee System?
The FDA product code for Triathlon® Hinge Knee System is KRO.
Related Clinical Trials
Other Devices by Howmedica Osteonics Corp., Dba Stryker Orthopaedics
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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.