BRM Digitalis Spacer
K-Number: K220142 · 2023-04-04
ApplicantBrm Extremities Srl
Decision Date2023-04-04
Product CodeKYJ
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
BRM Digitalis Spacer is a medical device manufactured by Brm Extremities Srl. It received FDA 510(k) clearance on 2023-04-04 under approval number K220142. The device is classified under product code KYJ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the BRM Digitalis Spacer?
BRM Digitalis Spacer is a medical device that received FDA 510(k) clearance on 2023-04-04. It is manufactured by Brm Extremities Srl. The 510(k) number is K220142.
When was BRM Digitalis Spacer approved by the FDA?
BRM Digitalis Spacer received FDA 510(k) clearance on 2023-04-04, under approval number K220142.
What company makes BRM Digitalis Spacer?
BRM Digitalis Spacer is manufactured by Brm Extremities Srl.
What is the FDA product code for BRM Digitalis Spacer?
The FDA product code for BRM Digitalis Spacer is KYJ.
Other Devices by Brm Extremities Srl
Related Devices (Code: KYJ)
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.