Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010376846

FEI Number

3010376846

Entity Name

OSYPKA MEDTEC INC.

City/State/Country

Longmont, CO, US

Establishment Address

1804 Skyway Dr Unit E, Longmont, CO 80504, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Repack or Relabel Medical Device

Owner / Operator

Osypka Medtec Inc. (Owner Number: 10044669)

Owner / Operator Contact Address

1804 Skyway Dr. Unit E, Longmont, CO 80504, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K153391

PMA Number

N/A

All Registered Proprietary Names

Otomag Alpha (M) Magnetic Implant

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LXB	Hearing Aid, Bone Conduction	Ear, Nose, Throat	Class 2	874.3302	2013-07-11
LXB	Hearing Aid, Bone Conduction	Ear, Nose, Throat	Class 2	874.3302	2017-03-07

Official Correspondent

Dana Tompkins

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Osypka Medtec Inc.

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 3010376846. Last updated year: 2026. Please use registration number 3010376846 when referencing this establishment in official correspondence.