Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003460151

FEI Number

3003322666

Entity Name

Splintek Inc.

City/State/Country

Lenexa, KS, US

Establishment Address

15555 W 108th Street, Lenexa, KS 66219, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Splintek Inc. (Owner Number: 9047750)

Owner / Operator Contact Address

15555 W 108th Street, --, Lenexa, KS 66219, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K250122

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LRK	Device, Anti-Snoring	Dental	Class 2	872.5570	2026-03-12

Official Correspondent

Thomas Brown

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Splintek Inc.

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
K122391	Medtronic Xomed, Inc.	MEDTRONIC XOMED, INC.	2013-01-10

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003460151. Last updated year: 2026. Please use registration number 3003460151 when referencing this establishment in official correspondence.