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Microtec SAS: FDA-registered device maker in Serres Castet Pyrenees-Atlantiques, France, 12 510(k) clearances

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

Microtec SAS is registered with the FDA (registration 3010365473) in Serres Castet Pyrenees-Atlantiques, France. It lists 7 device types. The FDA files 12 510(k) clearances under its listings, the newest dated August 10, 2021. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3010365473
Address: 41 rue dAyous, Serres Castet Pyrenees-Atlantiques, France, 64121
Owner or operator: Microtec SAS (10043532)
Roles: Manufacturer
First device listed: February 25, 2013
Registered through: 2026
Brand names listed: Kheiron Spinal Fixation System, S.M.A.I.O

Devices it lists

Device	Product code	Class	Role	Source
Appliance, Fixation, Spinal Interlaminal	KWP	2	Manufacturer	accessdata.fda.gov
Appliance, Fixation, Spinal Intervertebral Body	KWQ	2	Manufacturer	accessdata.fda.gov
Orthopedic Manual Surgical Instrument	LXH	1	Manufacturer	accessdata.fda.gov
Orthosis, Spinal Pedicle Fixation	MNI	2	Manufacturer	accessdata.fda.gov
Orthosis, Spondylolisthesis Spinal Fixation	MNH	2	Manufacturer	accessdata.fda.gov
Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis	OSH	2	Manufacturer	accessdata.fda.gov
Thoracolumbosacral Pedicle Screw System	NKB	2	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
August 10, 2021	K211414	KHEIRON Spinal Fixation System	NKB	Substantially Equivalent	S.M.A.I.O	accessdata.fda.gov
October 5, 2020	K201659	KHEIRON® Spinal Fixation System	NKB	Substantially Equivalent	S.M.A.I.O	accessdata.fda.gov
March 20, 2015	K150449	LITe Plate System	KWQ	Substantially Equivalent	Stryker Corp.	accessdata.fda.gov
January 15, 2015	K142741	OASYS System	KWP	Substantially Equivalent	Stryker Corporation	accessdata.fda.gov
October 21, 2014	K142381	Xia 3 Spinal System	NKB	Substantially Equivalent	Stryker Corp.	accessdata.fda.gov
November 20, 2013	K132603	APEX SPINE SYSTEM	NKB	Substantially Equivalent	Spinecraft, LLC	accessdata.fda.gov
August 28, 2012	K113666	XIA 3 SPINAL SYSTEM	NKB	Unknown	Stryker Spine	accessdata.fda.gov
June 22, 2012	K121342	XIA 4.5 SPINAL SYSTEM	NKB	Unknown	Stryker Corp.	accessdata.fda.gov
April 1, 2009	K083393	XIA 3 SPINAL SYSTEM	NKB	Substantially Equivalent	Stryker Spine	accessdata.fda.gov
March 6, 2006	K060361	XIA SPINAL SYSTEM, XIA 4.5 SPINAL SYSTEM	NKB	Substantially Equivalent	Stryker Spine	accessdata.fda.gov
October 11, 2005	K052761	MODIFICATION TO: XIA 4.5 SPINAL SYSTEM	MNI	Substantially Equivalent	Stryker Spine	accessdata.fda.gov
July 27, 2005	K050461	XIA 4.5 SPINAL SYSTEM	MNH	Substantially Equivalent	Stryker Spine	accessdata.fda.gov

Compare with other makers

Updated August 10, 2021. 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.