Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010860227

FEI Number

3010860227

Entity Name

VIRAK ORTHOPEDICS LLC

City/State/Country

Madison, NJ, US

Establishment Address

345 Main St, Ste 202, Madison, NJ 07940, US

Establishment Type(s)

Repack or Relabel Medical Device,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Virak Orthopedics LLC (Owner Number: 10046599)

Owner / Operator Contact Address

345 Main St, Ste 202, Madison, NJ 07940, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K132731

PMA Number

N/A

All Registered Proprietary Names

DigiFix DigiFix®

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JEC	Component, Traction, Invasive	Orthopedic	Class 2	888.3040	2019-11-12
JEC	Component, Traction, Invasive	Orthopedic	Class 2	888.3040	2014-04-12

Official Correspondent

Virak Tan

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Virak Orthopedics LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
9680825	ORTHOFIX SRL	BUSSOLENGO Verona, IT
3038503932	Smith & Nephew, Inc.	Memphis, TN, US
1720929	ISOMEDIX OPERATIONS INC.	Sandy, UT, US
3011500362	SPITREX ORTHOPEDICS SWITZERLAND SA	Le Locle Neuchatel, CH
1825034	BIOMET, INC.	WARSAW, IN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010860227. Last updated year: 2026. Please use registration number 3010860227 when referencing this establishment in official correspondence.