BRM TOOL Screws, BIOPLAN Subtalar Implant
K-Number: K222820 · 2022-12-16
ApplicantBrm Extremities
Decision Date2022-12-16
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
BRM TOOL Screws, BIOPLAN Subtalar Implant is a medical device manufactured by Brm Extremities. It received FDA 510(k) clearance on 2022-12-16 under approval number K222820. 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, BIOPLAN Subtalar Implant?
BRM TOOL Screws, BIOPLAN Subtalar Implant is a medical device that received FDA 510(k) clearance on 2022-12-16. It is manufactured by Brm Extremities. The 510(k) number is K222820.
When was BRM TOOL Screws, BIOPLAN Subtalar Implant approved by the FDA?
BRM TOOL Screws, BIOPLAN Subtalar Implant received FDA 510(k) clearance on 2022-12-16, under approval number K222820.
What company makes BRM TOOL Screws, BIOPLAN Subtalar Implant?
BRM TOOL Screws, BIOPLAN Subtalar Implant is manufactured by Brm Extremities.
What is the FDA product code for BRM TOOL Screws, BIOPLAN Subtalar Implant?
The FDA product code for BRM TOOL Screws, BIOPLAN Subtalar Implant 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.