BRM TOOL Screws
K-Number: K203773 · 2022-01-14
ApplicantBrm Extremities Srl
Decision Date2022-01-14
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
BRM TOOL Screws is a medical device manufactured by Brm Extremities Srl. It received FDA 510(k) clearance on 2022-01-14 under approval number K203773. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the BRM TOOL Screws?
BRM TOOL Screws is a medical device that received FDA 510(k) clearance on 2022-01-14. It is manufactured by Brm Extremities Srl. The 510(k) number is K203773.
When was BRM TOOL Screws approved by the FDA?
BRM TOOL Screws received FDA 510(k) clearance on 2022-01-14, under approval number K203773.
What company makes BRM TOOL Screws?
BRM TOOL Screws is manufactured by Brm Extremities Srl.
What is the FDA product code for BRM TOOL Screws?
The FDA product code for BRM TOOL Screws is HWC. This falls under the Cardiovascular category.
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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.