Ototronix, LLC (Minnesota)

FDA Device Registration & Listing · White Bear Township, MN, US · Registration 3012118649

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3012118649
FEI Number
3012118649
Entity Name
Ototronix, LLC (Minnesota)
City/State/Country
White Bear Township, MN, US
Establishment Address
5000 Township Pkwy, White Bear Township, MN 55110, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Ototronix, LLC (Owner Number: 10031730)
Owner / Operator Contact Address
5000 Township Parkway, Saint Paul, MN 55110, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K140644
PMA Number
N/A

All Registered Proprietary Names

Maxum ProCem

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MPV Implant, Hearing, Active, Middle Ear, Partially Implanted Unknown Class 3 N/A 2010-03-03
NEA Cement, Ear, Nose And Throat Dental Class 2 872.3275 2014-07-25

Official Correspondent

Brant Newman

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Ototronix, LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K042516 Walter Lorenz Surgical, Inc. OTOMIMIX 2004-11-08

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012118649. Last updated year: 2026. Please use registration number 3012118649 when referencing this establishment in official correspondence.
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