Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005983700

FEI Number

3005983700

Entity Name

Societe Marnaise D'Applications Orthopediques (SMAO) Sarl

City/State/Country

Villiers Le Sec Haute-Marne, FR

Establishment Address

Aerodrome 52000, Villiers Le Sec Haute-Marne 52000, FR

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Societe Marnaise D'Applications Orthopediques (SMAO) SAS (Owner Number: 10055341)

Owner / Operator Contact Address

Aerodrome, Villiers Le Sec, FR-NOTA 52000, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT Plate, fixation, bone Bit, Drill Orthopedic manual surgical instrument

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2019-03-27
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2020-12-17
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2017-07-10
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2017-07-10

Official Correspondent

Magalie HENNEQUIN

US Agent Details

Yong Sun Business: Emergo Global Representation LLC Email: USAgent@ul.com Phone: (512) 3279997

Related Public Records

Same Entity

Societe Marnaise D'Applications Orthopediques (SMAO) SAS

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
K042598	Zimmer, Inc.	PERIARTICULAR LOCKING PLATES AND SCREWS, 2357 AND 2359 SERIES	2004-10-29
K190842	Jiangsu Trauhui Medical Instrument Co., Ltd.	Comus Locking Plate systems	2020-02-03
K130510	Arthrex, Inc.	ARTHREX COMPRESSION PLATES	2013-09-25
K202803	Newclip Technics	Activmotion S DTO	2021-12-16

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0034-2022	Flower Orthopedics Corporation	2	Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
Z-0009-2007	Smith & Nephew Inc	1	Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817.
Z-0010-2007	Smith & Nephew Inc	1	Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486
Z-0011-06	Stryker Howmedica Osteonics Corp.	1	Allocraft TLIF Bone Inserter.
Z-0011-2007	Smith & Nephew Inc	1	Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71927102, 71927103, 71927104, 71927105

Similar Registrations

Registration Number	Establishment Name	Location
3014725904	Medtronic Medical Costa Rica S.R.L.	Coyol Alajuela, CR
3040335671	Stryker Ireland Ltd. Instruments Division, Innovation Centre	Carrigtwohill Cork (County), IE
3010363503	FRUEH VERPACKUNGSTECHNIK AG	Fehraltorf Zurich, CH
3010287737	BAECHLER FEINTECH AG	Hoelstein Basel-Landschaft, CH
3010673850	MK medical GmbH	Emmingen-Liptingen Baden-Wurttemberg, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005983700. Last updated year: 2026. Please use registration number 3005983700 when referencing this establishment in official correspondence.