510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K984357Substantially Equivalent

Transfx External Fixation System

Immedica, Inc., Chatham NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K984357 is the FDA 510(k) clearance record for TRANSFX EXTERNAL FIXATION SYSTEM, a class II device, cleared for Immedica, Inc. on under FDA product code LXT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite). FDA records list 8 510(k) clearances for Immedica, Inc., from to . As of , FDA records show 7 recalls naming K984357.

Clearance record

Decision date
Received
(87 days to decision)
Product code
LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
Regulation
21 CFR 888.3030
Device class
Class II
Review panel
Orthopedic
Applicant
Immedica, Inc. 100 Passaic Ave., Chatham NJ
510(k) summary
Statement
Third party review
No

Clearances, product code LXT

Trailing 12 months

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

FDA records show no clearances under product code LXT in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LXT, 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