Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1835305

FEI Number

3000203601

Entity Name

Masterbilt Incorporated

City/State/Country

South Bend, IN, US

Establishment Address

3801 Voorde Dr, South Bend, IN 46628, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Masterbilt Incorporated (Owner Number: 10084599)

Owner / Operator Contact Address

3801 Voorde Drive, South Bend, IN 46628, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Medtronic

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HWT	Template	Orthopedic	Class 1	888.4800	2026-03-11

Official Correspondent

Rob Michalak

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Masterbilt Incorporated

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1835305. Last updated year: 2026. Please use registration number 1835305 when referencing this establishment in official correspondence.