Tyber Medical Distal Radius Plating System
K-Number: K251361 · 2025-07-30
ApplicantTyber Medical, LLC
Decision Date2025-07-30
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Tyber Medical Distal Radius Plating System is a medical device manufactured by Tyber Medical, LLC. It received FDA 510(k) clearance on 2025-07-30 under approval number K251361. 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 Tyber Medical Distal Radius Plating System?
Tyber Medical Distal Radius Plating System is a medical device that received FDA 510(k) clearance on 2025-07-30. It is manufactured by Tyber Medical, LLC. The 510(k) number is K251361.
When was Tyber Medical Distal Radius Plating System approved by the FDA?
Tyber Medical Distal Radius Plating System received FDA 510(k) clearance on 2025-07-30, under approval number K251361.
What company makes Tyber Medical Distal Radius Plating System?
Tyber Medical Distal Radius Plating System is manufactured by Tyber Medical, LLC.
What is the FDA product code for Tyber Medical Distal Radius Plating System?
The FDA product code for Tyber Medical Distal Radius Plating System is HRS.
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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.