510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K132731Substantially Equivalent

Digifix External Fixation System

Virak Orthopedic Research, LLC, Bartlett TN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K132731 is the FDA 510(k) clearance record for DIGIFIX EXTERNAL FIXATION SYSTEM, a class II device, cleared for Virak Orthopedic Research, LLC on under FDA product code JEC (Component, Traction, Invasive). FDA records list one 510(k) clearance for Virak Orthopedic Research, LLC. As of , FDA records show no recalls naming K132731.

Clearance record

Decision date
Received
(129 days to decision)
Product code
JEC Component, Traction, Invasive
Regulation
21 CFR 888.3040
Device class
Class II
Review panel
Orthopedic
Applicant
Virak Orthopedic Research, LLC 3416 Roxee Run Cove, Bartlett TN
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