RODIN Cement
K-Number: K251775 · 2025-09-02
ApplicantBelport Company, Inc., Gingi-Pak
Decision Date2025-09-02
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
RODIN Cement is a medical device manufactured by Belport Company, Inc., Gingi-Pak. It received FDA 510(k) clearance on 2025-09-02 under approval number K251775. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the RODIN Cement?
RODIN Cement is a medical device that received FDA 510(k) clearance on 2025-09-02. It is manufactured by Belport Company, Inc., Gingi-Pak. The 510(k) number is K251775.
When was RODIN Cement approved by the FDA?
RODIN Cement received FDA 510(k) clearance on 2025-09-02, under approval number K251775.
What company makes RODIN Cement?
RODIN Cement is manufactured by Belport Company, Inc., Gingi-Pak.
What is the FDA product code for RODIN Cement?
The FDA product code for RODIN Cement is EMA.
Other Devices by Belport Company, Inc., Gingi-Pak
Related Devices (Code: EMA)
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.