RODIN 3D Resin SPLINT, Hard/Flex
K-Number: K231793 · 2024-03-26
ApplicantBelport Company, Inc., Gingi-Pak
Decision Date2024-03-26
Product CodeMQC
DecisionSubstantially Equivalent
Device Summary
RODIN 3D Resin SPLINT, Hard/Flex is a medical device manufactured by Belport Company, Inc., Gingi-Pak. It received FDA 510(k) clearance on 2024-03-26 under approval number K231793. The device is classified under product code MQC. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the RODIN 3D Resin SPLINT, Hard/Flex?
RODIN 3D Resin SPLINT, Hard/Flex is a medical device that received FDA 510(k) clearance on 2024-03-26. It is manufactured by Belport Company, Inc., Gingi-Pak. The 510(k) number is K231793.
When was RODIN 3D Resin SPLINT, Hard/Flex approved by the FDA?
RODIN 3D Resin SPLINT, Hard/Flex received FDA 510(k) clearance on 2024-03-26, under approval number K231793.
What company makes RODIN 3D Resin SPLINT, Hard/Flex?
RODIN 3D Resin SPLINT, Hard/Flex is manufactured by Belport Company, Inc., Gingi-Pak.
What is the FDA product code for RODIN 3D Resin SPLINT, Hard/Flex?
The FDA product code for RODIN 3D Resin SPLINT, Hard/Flex is MQC.
Related Clinical Trials
Other Devices by Belport Company, Inc., Gingi-Pak
Related Devices (Code: MQC)
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.