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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Brm Extremities Srl. It received FDA 510(k) clearance on 2022-01-14 under 510(k) 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. The listed applicant is Brm Extremities Srl. The 510(k) number is K203773.

When did BRM TOOL Screws receive FDA 510(k) clearance?

BRM TOOL Screws received FDA 510(k) clearance on 2022-01-14, under 510(k) number K203773.

Who is the listed applicant for BRM TOOL Screws?

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

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.

Other records listing Brm Extremities Srl 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.

K220142BRM Digitalis Spacer

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.

K262344Large Compression ScrewsTriMed, Inc.K253858GFS - Sterile Screws and Top HatT.A.G. Medical Products Corporation, Ltd.K262075Lapidus Screw KitRelja Innovations, LLCK260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.K253108VEOFIX Snap Off ScrewSteps OrthoK261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC

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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