FDA 510(k)

BRM Digitalis Spacer

K-Number: K220142 · 2023-04-04

Decision Date2023-04-04

Product CodeKYJ

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

BRM Digitalis Spacer 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 2023-04-04 under 510(k) 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. The listed applicant is Brm Extremities Srl. The 510(k) number is K220142.

When did BRM Digitalis Spacer receive FDA 510(k) clearance?

BRM Digitalis Spacer received FDA 510(k) clearance on 2023-04-04, under 510(k) number K220142.

Who is the listed applicant for BRM Digitalis Spacer?

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 Digitalis Spacer?

The FDA product code for BRM Digitalis Spacer is KYJ.

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.

K203773BRM TOOL Screws

Related Devices (Code: KYJ)

K233670Ascension Silicone MCP; Ascension Silicone PIPAscension Orthopedics, Inc.K211385KeriFlex® MCP and PIP Finger Joint ProsthesesKeri Medical SA

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.