Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013561205

FEI Number

3013561205

Entity Name

3D-SIDE

City/State/Country

Mont Saint Guibert Brabant Wallon, BE

Establishment Address

Rue Dumont, 5, Mont Saint Guibert Brabant Wallon 1435, BE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

3D-Side (Owner Number: 10054501)

Owner / Operator Contact Address

Rue Andre Dumont 5, Mont Saint Guibert, BE-WBR 1435, BE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K213779

PMA Number

N/A

All Registered Proprietary Names

Archer PSI System 3D-Ankle PLAN ARCHER 3D

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2025-06-25
QHE	Shoulder Arthroplasty Implantation System	Orthopedic	Class 2	888.3660	2025-06-25
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2025-06-25
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2023-01-03
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2023-01-03

Official Correspondent

Khanh Tran Duy

US Agent Details

Jason Lansdown Email: jason.lansdown@3dside.eu Phone: (303) 4826785

Related Public Records

Same Entity

3D-Side

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
K141345	Tornier S.A.S.	AEQUALIS FX2	2014-11-18
K904879	Endotec, Inc.	BEUCHEL-PAPPAS GLENOID COMPONENT	1991-01-28
K242270	Orthofix Srl	OrthoNext Platform System	2024-12-19
K261713	FUJIFILM Healthcare Americas Corporation	Synapse PACS (7.6.0)	2026-06-18
K243647	FUJIFILM Healthcare Americas Corporation	Synapse PACS (7.5)	2025-06-30

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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013561205. Last updated year: 2026. Please use registration number 3013561205 when referencing this establishment in official correspondence.