510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K220142Substantially Equivalent

BRM Digitalis Spacer

BRM Extremities SRL, Civate, IT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K220142 is the FDA 510(k) clearance record for BRM Digitalis Spacer, a class II device, cleared for Brm Extremities Srl on under FDA product code KYJ (Prosthesis, Finger, Constrained, Polymer). FDA records list 4 510(k) clearances for Brm Extremities Srl, from to . As of , FDA records show no recalls naming K220142.

Clearance record

Decision date
Received
(441 days to decision)
Product code
KYJ Prosthesis, Finger, Constrained, Polymer
Regulation
21 CFR 888.3230
Device class
Class II
Review panel
Orthopedic
Applicant
Brm Extremities Srl Via Papa Giovanni Xxiii, 9, Civate, IT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KYJ

Trailing 12 months

FDA records hold no clearances under product code KYJ in the trailing twelve months.

FDA records show no clearances under product code KYJ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KYJ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260