Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3002993234

FEI Number

3002993234

Entity Name

SMB MEDICAL SA

City/State/Country

Sant'Antonino Ticino, CH

Establishment Address

Via Serrai 14, Sant'Antonino Ticino 6592, CH

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

SMB MEDICAL SA (Owner Number: 10059430)

Owner / Operator Contact Address

Via Serrai 14, Sant'Antonino, CH-TI 6592, CH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2020-09-21
PKC	Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained	Orthopedic	Class 2	888.3660	2020-07-10
QHQ	Total Shoulder Arthroplasty System	Orthopedic	Class 2	888.3660	2020-07-10
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-12-19
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2021-01-07
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2019-01-16
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2021-11-05
PKC	Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained	Orthopedic	Class 2	888.3660	2019-09-12
QHQ	Total Shoulder Arthroplasty System	Orthopedic	Class 2	888.3660	2019-09-12
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2022-02-01

Official Correspondent

No official correspondent registered.

US Agent Details

Kriss Anderson Business: Tangible Solutions Inc. dba Marle Tangible Email: kanderson@tangiblesolutions3d.com Phone: (937) 9124603

Related Public Records

Same Entity

SMB MEDICAL 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
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
K222566	Zimmer, Inc.	Zimmer Persona Personalized Knee System	2022-10-17

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

Similar Registrations

Registration Number	Establishment Name	Location
3013843055	BEIJING AK MEDICAL CO, LTD	Changping District Beijing, CN
3022777867	FIXIER S.A. DE C.V.	Doctor Mora Guanajuato, MX
3017209758	NEBULA SURGICAL PRIVATE LIMITED	Rajkot Gujarat, IN
3017609305	PRIMEMED INC.	Sungnam-city Gyeonggi, KR
3015410662	Jabil Inc. (Wilson Drive)	W Chester, PA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3002993234. Last updated year: 2026. Please use registration number 3002993234 when referencing this establishment in official correspondence.