Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004126422

FEI Number

3004126422

Entity Name

Trelleborg Sealing Solutions Litchfield

City/State/Country

Litchfield, MN, US

Establishment Address

45 N Precision Dr, Litchfield, MN 55355, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Trelleborg Sealing Solutions Plymouth LLC (Owner Number: 9102441)

Owner / Operator Contact Address

1100 XENIUM LANE NORTH, --, Minneapolis, MN 55441, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

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
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2013-02-19
KWL	Prosthesis, Hip, Hemi-, Femoral, Metal	Orthopedic	Class 2	888.3360	2020-01-14
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2020-01-14

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Trelleborg Sealing Solutions Plymouth LLC

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3002939152	Trelleborg Sealing Solutions River Falls	River Falls, WI, US
3008770653	Trelleborg Sealing Solutions Suzhou Company Limited	Suzhou Jiangsu, CN
3009307663	Trelleborg Sealing Solutions Weobley Limited	Weobley Herefordshire, GB

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K260601	Blue Belt Technologies, Inc.	REAL INTELLIGENCE CORI	2026-03-26
K823482	Intermedics Orthopedics	101 UNIVERSAL ENDOPROSTHESIS	1983-02-07

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0041-2024	Blue Belt Technologies, Inc	2	Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004126422. Last updated year: 2026. Please use registration number 3004126422 when referencing this establishment in official correspondence.