Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003403260

FEI Number

3003403260

Entity Name

SQ PRODUCTS AG

City/State/Country

Inwil Luzern, CH

Establishment Address

Industriestrasse 23, Inwil Luzern 6034, CH

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

SQ Products AG (Owner Number: 10043435)

Owner / Operator Contact Address

Industriestrasse 23, Inwil, CH-LU 6034, CH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Arthrex Eclipse Shoulder Prosthesis System Arthrex Fracture Adapter Hemi Shoulder Prosthesis Arthrex Eclipse Titanium Humeral Head Trial, Cup, Size 33+2, Left, 155 degree Trial, Cup, Size 33+2, Right, 135 degree Trial, Cup, Size 33+2, Left, 135 degree Trial, Cup, Size 33+2, Right, 155 degree Trial, Cup, Size 33, 155 degree Trial, Cup, Size 33, 135 degree Univers Revers Humeral Cup Implant Univers Revers Modular Glenoid System Arthrex Univers Revers Monoblock Stem Size 4/33 Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral Heads

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PKC	Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained	Orthopedic	Class 2	888.3660	2019-08-08
QHQ	Total Shoulder Arthroplasty System	Orthopedic	Class 2	888.3660	2019-08-08
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2013-02-15
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2013-02-15
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2014-02-24
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2018-05-01
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2016-12-22
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2016-12-22
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2020-10-12
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2020-10-12
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2013-02-15
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2013-02-15
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2013-02-15
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2013-02-15
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2018-07-12
PKC	Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained	Orthopedic	Class 2	888.3660	2020-11-23
QHQ	Total Shoulder Arthroplasty System	Orthopedic	Class 2	888.3660	2020-11-23
HWT	Template	Orthopedic	Class 1	888.4800	2022-05-09
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2016-05-10
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2022-05-24
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2022-05-24
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2020-01-29
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2023-05-01
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2023-05-01
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2020-11-17

Official Correspondent

Mirella Gora

US Agent Details

Cherita James Business: Pro Pharma Group Email: cherita.james@propharmagroup.com Phone: (347) 9540624

Related Public Records

Same Entity

SQ Products AG

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
K984202	Howmedica, Inc.	HOWMEDICA HUMERAL INTERCALARY SYSTEM	1999-02-05
K904879	Endotec, Inc.	BEUCHEL-PAPPAS GLENOID COMPONENT	1991-01-28
K141345	Tornier S.A.S.	AEQUALIS FX2	2014-11-18

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0023-06	Zimmer Inc.	2	Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 40 mm dia. articular surface, small, sterile, for cemented use only in the USA, Cat. no. 00430604000.
Z-0024-06	Zimmer Inc.	2	Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 46 mm dia. articular surface, small, sterile, for cemented use only in the USA, Cat. no. 00430604046.
Z-0025-06	Zimmer Inc.	2	Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 40 mm dia. articular surface, med, sterile, for cemented use only in the USA, Cat. no. 00430604640.
Z-0026-06	Zimmer Inc.	2	Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 46 mm dia. articular surface, med, sterile, for cemented use only in the USA, Cat. no. 00430604600.
Z-0027-06	Zimmer Inc.	2	Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 52 mm dia. articular surface, med, sterile, for cemented use only in the USA, Cat. no. 00430604652.

Similar Registrations

Registration Number	Establishment Name	Location
3007051929	MEDICAL GROUP	SAINT-PRIEST Auvergne-Rhone-Alpes, FR
3014004349	Arthrex Singapore Pte Ltd.	Singapore Central Singapore, SG
1818910	DEPUY ORTHOPAEDICS, INC.	WARSAW, IN, US
3015516266	Depuy Ireland UC	Co. Cork Munster, IE
3014262693	Arthrex (Shanghai) Co., Ltd.	Shanghai, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003403260. Last updated year: 2026. Please use registration number 3003403260 when referencing this establishment in official correspondence.