Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014027736

FEI Number

3014027736

Entity Name

IMASCAP

City/State/Country

PLOUZANE Finistere, FR

Establishment Address

65 place Nicolas Copernic, PLOUZANE Finistere 29280, FR

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

STRYKER CORP. (Owner Number: 1811755)

Owner / Operator Contact Address

4100 East Milham Ave., Kalamazoo, MI 49001, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K143374

PMA Number

N/A

All Registered Proprietary Names

BLUEPRINT Patient Specific Instrumentation Blueprint Patient Specific Instrumentation Tornier Perform Patient-Matched Primary Reversed Glenoid Shoulder iD Shoulder iD Primary Reversed Glenoid BLUEPRINT Patient Specific Instrumentation BluePrint BLUEPRINT Patient Specific Instrumentation

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2021-04-23
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2021-12-06
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2021-12-06
QHE	Shoulder Arthroplasty Implantation System	Orthopedic	Class 2	888.3660	2021-12-06
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2021-04-23
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2021-04-23
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2021-04-23

Official Correspondent

No official correspondent registered.

US Agent Details

Jeanine Redden Email: jeanine.redden@stryker.com Phone: (901) 8674522

Related Public Records

Same Entity

STRYKER CORP.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3003897776	BIOMIMETIC THERAPEUTICS,LLC	FRANKLIN, TN, US
3040801290	Inari Medical, Costa Rica S.A.	Grecia Alajuela, CR
2031049	TMJ Solutions, LLC	San Buenaventura, CA, US
3016573902	Ortho-Space Ltd.	Caesarea Haifa, IL
3010411911	POM Medical, LLC	Moorpark, CA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014027736. Last updated year: 2026. Please use registration number 3014027736 when referencing this establishment in official correspondence.