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Medtech SAS: FDA-registered device maker in MAUGUIO Occitanie, France, 4 510(k) clearances

Name: Medtech SAS FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Medtech SAS is registered with the FDA (registration 3009185973) in MAUGUIO Occitanie, France. It lists 5 device types. The FDA files 4 510(k) clearances under its listings, the newest dated July 20, 2023. 4 recall events name it as the recalling firm (2 Class I). Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3009185973
Address: 432 rue du Rajol, MAUGUIO Occitanie, France, 34130
Owner or operator: MEDTECH S.A.S (10034131)
Roles: Contract manufacturer, Exporter to the US, Manufacturer
First device listed: October 31, 2017
Registered through: 2026
Brand names listed: ROSA HIP, ROSA Knee System, ROSA ONE Brain application, ROSA One Brain Application, ROSA One Brain application, ROSA Partial Knee System, ROSA® Knee System, Rosa and more

Devices it lists

Device	Product code	Class	Role	Source
Drape, Surgical, Antimicrobial	KKX	2	Exporter to the US	accessdata.fda.gov
Drape, Surgical, Exempt	PUI	2	Exporter to the US	accessdata.fda.gov
Neurological Stereotaxic Instrument	HAW	2	Manufacturer	accessdata.fda.gov
Orthopedic Stereotaxic Instrument	OLO	2	Contract manufacturer	accessdata.fda.gov
System, Image Processing, Radiological	LLZ	2	Contract manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
July 20, 2023	K231103	ROSA ONE Brain Application	HAW	Substantially Equivalent	Medtech S.A.S	accessdata.fda.gov
May 4, 2022	K214065	ROSA ONE Brain application	HAW	Substantially Equivalent	Medtech S.A.S	accessdata.fda.gov
May 29, 2020	K200511	ROSA ONE Brain application	HAW	Substantially Equivalent	Medtech S.A	accessdata.fda.gov
May 17, 2005	K050322	MICROTEK EQUIPMENT DRAPES	KKX	Substantially Equivalent	Microtek Medical, Inc.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
September 22, 2021	88746	Class I	Ongoing	ROSA One 3.1 Brain application The device is intended for the spatial positioning and orientation of instruments holders or tool guides to be used by trained surgeons to guide standard surgical instruments during brain a	The firm has become aware of a software anomaly affecting ROSA One 3.1 Brain application which led to the inaccurate placement of an electrode during surgery. The firm has received 3 global complaints related to the issue. An incorrect trajectory could result in serious injury or death if undetected during surgery.	accessdata.fda.gov
January 6, 2020	84642	Class II	Terminated	ROSA Brain 3.0 Application-Brain	Some cross-sectional images from the image acquisitions of the patients head may not be reconstructed/displayed properly in two and three dimension views when using ROSA Brain software, potentially compromising the surgery planning.	accessdata.fda.gov
September 10, 2019	83665	Class I	Terminated	Rosa Brain 3.0, Model No. ROSA 3.0. The device is delivered assembled in a wooden case and protected with plastic bubble and plastic film. Seals are put on the crate. The product is not shipped sterile. The device is int	The instrument holder may be sent on a trajectory that is not within the intended target. If it is not corrected, the associated device may be placed incorrectly.	accessdata.fda.gov
May 8, 2018	80061	Class II	Terminated	ROSA(TM) Robotized Stereotactic Assistant, Version 2.5 ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of a	Replacement of units lacking an updated device approval.	accessdata.fda.gov

Compare with other makers

Updated July 20, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.