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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Brm Extremities. It received FDA 510(k) clearance on 2022-12-16 under 510(k) 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. The listed applicant is Brm Extremities. The 510(k) number is K222820.

When did BRM TOOL Screws, BIOPLAN Subtalar Implant receive FDA 510(k) clearance?

BRM TOOL Screws, BIOPLAN Subtalar Implant received FDA 510(k) clearance on 2022-12-16, under 510(k) number K222820.

Who is the listed applicant for BRM TOOL Screws, BIOPLAN Subtalar Implant?

The FDA 510(k) record lists Brm Extremities as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Brm Extremities as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K191966NewPrim System

Related Devices (Code: HWC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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