Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003916006

FEI Number

3003916006

Entity Name

LABORATORIOS SL SA

City/State/Country

Malvinas Argentinas Buenos Aires, AR

Establishment Address

Estados Unidos 4503, Malvinas Argentinas Buenos Aires B1667JHA, AR

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

LABORATORIOS SL SA (Owner Number: 10042844)

Owner / Operator Contact Address

Curupayti 2611, San Fernando, AR-B 1644, AR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Synicem Synicem Hip, Knee, and Shoulder Spacers

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HWT	Template	Orthopedic	Class 1	888.4800	2025-08-13
KWL	Prosthesis, Hip, Hemi-, Femoral, Metal	Orthopedic	Class 2	888.3360	2025-08-12
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2025-08-12
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2025-08-12
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2025-08-12
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2025-08-12
NDN	Cement, Bone, Vertebroplasty	Orthopedic	Class 2	888.3027	2021-05-27

Official Correspondent

Fernando Saba

US Agent Details

Kathleen Moon Email: akm@biocomposites.com Phone: (910) 3508015

Related Public Records

Same Entity

LABORATORIOS SL SA

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
K904879	Endotec, Inc.	BEUCHEL-PAPPAS GLENOID COMPONENT	1991-01-28
K984202	Howmedica, Inc.	HOWMEDICA HUMERAL INTERCALARY SYSTEM	1999-02-05
K823482	Intermedics Orthopedics	101 UNIVERSAL ENDOPROSTHESIS	1983-02-07
K901338	Kirschner Medical Corp.	KIRSCHNER MODULAR TCIV TOTAL KNEE SYSTEM	1990-05-22
K030577	Stelkast Company	PROVEN MODULAR TIBIAL TRAY	2003-03-25

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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3009631939	RED STAR CONTRACT MANUFACTURING INC.	Larwill, IN, US
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003916006. Last updated year: 2026. Please use registration number 3003916006 when referencing this establishment in official correspondence.