510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K192465Substantially Equivalent

DigiFix Sterile Kit

Virak Orthopedics LLC, Harrison NJ / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K192465 is the FDA 510(k) clearance record for DigiFix Sterile Kit, a class II device, cleared for Virak Orthopedics, LLC on under FDA product code JEC (Component, Traction, Invasive). FDA records list one 510(k) clearance for Virak Orthopedics, LLC. As of , FDA records show no recalls naming K192465.

Clearance record

Decision date
Received
(31 days to decision)
Product code
JEC Component, Traction, Invasive
Regulation
21 CFR 888.3040
Device class
Class II
Review panel
Orthopedic
Applicant
Virak Orthopedics, LLC 620 Essex St., Harrison NJ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JEC

Trailing 12 months

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

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