BRM Digitalis Spacer— 510(k) K220142

Name: FDA 510(k) clearance K220142
Creator: U.S. Food and Drug Administration
Published: 2023-04-04

Substantially Equivalent

Brm Extremities Srl

FDA 510(k) clearance K220142 for BRM Digitalis Spacer, Substantially Equivalent on 2023-04-04. Applicant: Brm Extremities Srl. Device class: 2.

Clearance details

Applicant: Brm Extremities Srl
Product code: Code KYJ
Device class: Class 2
Regulation: 21 CFR 888.3230
Advisory panel: Orthopedic
Date received: 2022-01-18
Decision date: 2023-04-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Civate, IT

Download summary PDF View on FDA.gov ↗

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K140453 — OSTEOTEC SILICONE FINGER IMPLANT2015-04-17
K083107 — MODIFICATION TO DEPUY NEUFLEX PIP FINGER2009-02-09
K082231 — ASCENSION SILICONE PIP2009-01-12

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K203773 — BRM TOOL Screws2022-01-14

Adverse events under product code KYJ

product code KYJ

Injury: 210
Total: 210

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.