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Data / Medical devices / France / Medicrea International

Medicrea International: FDA-registered device maker in RILLIEUX-LA-PAPE Auvergne-Rhone-Alpes, France, 27 510(k) clearances

Medicrea International is registered with the FDA (registration 1000432246) in RILLIEUX-LA-PAPE Auvergne-Rhone-Alpes, France. It lists 31 device types. The FDA files 27 510(k) clearances under its listings, the newest dated May 15, 2026. 9 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Medicrea International
FDA registration number
1000432246
Address
5389 route de Strasbourg - Vancia, RILLIEUX-LA-PAPE Auvergne-Rhone-Alpes, France, 69140
Owner or operator
Medtronic, Inc. (2112641)
Roles
Manufacturer, Specification developer
First device listed
February 15, 1978
Registered through
2026
Brand names listed
Aspen, BIT DRILLS, BONE TAP, Bard-Parker, C-Curve, CD Horizon™ ModuLeX™ Spinal System, CD Horizon™ Spinal System, CD Horizon™ Spinal System and PASS LP™ Spinal System and more

Devices it lists

DeviceProduct codeClassRoleSource
Appliance, Fixation, Spinal InterlaminalKWP2Manufactureraccessdata.fda.gov
Appliance, Fixation, Spinal Intervertebral BodyKWQ2Manufactureraccessdata.fda.gov
Automated Radiological Image Processing SoftwareQIH2Specification developeraccessdata.fda.gov
BenderHXW1Manufactureraccessdata.fda.gov
Bit, DrillHTW1Manufactureraccessdata.fda.gov
Bone Fixation Cerclage, SublaminarOWI2Manufactureraccessdata.fda.gov
ExtractorHWB1Manufactureraccessdata.fda.gov
Gauge, DepthHTJ1Manufactureraccessdata.fda.gov
ImpactorHWA1Manufactureraccessdata.fda.gov
Instrument, Cutting, OrthopedicHTZ1Manufactureraccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, CervicalODP2Manufactureraccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, LumbarMAX2Manufactureraccessdata.fda.gov
Intervertebral Fusion Device With Integrated Fixation, CervicalOVE2Manufactureraccessdata.fda.gov
Intervertebral Fusion Device With Integrated Fixation, LumbarOVD2Manufactureraccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Manufactureraccessdata.fda.gov
Orthosis, Spinal Pedicle FixationMNI2Manufactureraccessdata.fda.gov
Orthosis, Spondylolisthesis Spinal FixationMNH2Manufactureraccessdata.fda.gov
Pedicle Screw Spinal System, Adolescent Idiopathic ScoliosisOSH2Manufactureraccessdata.fda.gov
Posterior Cervical Screw SystemNKG2Manufactureraccessdata.fda.gov
ProbeHXB1Manufactureraccessdata.fda.gov
ReamerHTO1Manufactureraccessdata.fda.gov
ScrewdriverHXX1Manufactureraccessdata.fda.gov
Spatula, OrthopedicHXR1Manufactureraccessdata.fda.gov
System, Image Processing, RadiologicalLLZ2Manufacturer, Specification developeraccessdata.fda.gov
System, X-Ray, Film Marking, RadiographicJAC1Manufactureraccessdata.fda.gov
TampHXG1Manufactureraccessdata.fda.gov
Tap, BoneHWX1Manufactureraccessdata.fda.gov
TemplateHWT1Manufactureraccessdata.fda.gov
Thoracolumbosacral Pedicle Screw SystemNKB2Manufactureraccessdata.fda.gov
Tray, Surgical, InstrumentFSM1Manufactureraccessdata.fda.gov
WrenchHXC1Manufactureraccessdata.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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
May 15, 2026K261289UNiD™ Spine Analyzer (SW3002)QIHSubstantially EquivalentMedicrea International S.A.S. (Medtronic)accessdata.fda.gov
August 7, 2025K251629UNiD™ Spine AnalyzerQIHSubstantially EquivalentMedicrea International S.A.S. (Medtronic)accessdata.fda.gov
September 6, 2024K241164IB3D™ PL Spinal SystemMAXSubstantially EquivalentMedicrea International S.A.S. (Medtronic)accessdata.fda.gov
April 19, 2022K220810Infinity™ OCT System and PASS OCT Spinal SystemNKGSubstantially EquivalentMedicrea Internationalaccessdata.fda.gov
April 8, 2022K220724CD Horizon™ Spinal System and PASS LP™ Spinal SystemNKBSubstantially EquivalentMedicrea Internationalaccessdata.fda.gov
January 12, 2022K212005UNiD Spine AnalyzerLLZSubstantially EquivalentMedicrea International, Inc.accessdata.fda.gov
January 5, 2022K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemNKBSubstantially EquivalentMedicrea International SAaccessdata.fda.gov
September 3, 2021K210470C-CURVE Interbody Fusion DeviceOVESubstantially EquivalentMedicrea International SAaccessdata.fda.gov
May 2, 2019K190376PASS LP Spinal SystemNKBSubstantially EquivalentMedicrea International SAaccessdata.fda.gov
October 17, 2018K182240PASS LP Spinal SystemNKBSubstantially EquivalentMedicrea International SAaccessdata.fda.gov
April 3, 2018K173506LigaPASSOWISubstantially EquivalentMedicrea International SAaccessdata.fda.gov
November 13, 2017K163595IMPIX 3D Print CagesMAXSubstantially EquivalentMedicrea International SAaccessdata.fda.gov
August 30, 2017K172021LigaPASSOWISubstantially EquivalentMedicrea International SAaccessdata.fda.gov
January 25, 2017K162786PASS LP Spinal SystemNKBSubstantially EquivalentMedicrea International SAaccessdata.fda.gov
April 22, 2016K153413PASS LP Spinal SystemNKBSubstantially EquivalentMedicrea International SAaccessdata.fda.gov
January 29, 2016K153169PASS OCT Patient Specific RodsNKGSubstantially EquivalentMedicrea Internationalaccessdata.fda.gov
October 16, 2015K150918PASS OCT Spinal SystemNKGSubstantially EquivalentMedicrea International SAaccessdata.fda.gov
January 15, 2015K141187IMPIX ALIF S/AOVDSubstantially EquivalentMedicrea International SAaccessdata.fda.gov
January 9, 2015K141398PASS LP SPINAL SYSTEMNKBSubstantially EquivalentMedicrea International SAaccessdata.fda.gov
November 4, 2014K140738PASS LP SPINAL SYSTEMMNISubstantially EquivalentMedicrea Internationalaccessdata.fda.gov
December 6, 2013K132395LIGAPASSOWISubstantially EquivalentMedicrea Internationalaccessdata.fda.gov
November 8, 2013K132574PASS LP SPINAL SYSTEMOSHSubstantially EquivalentMedicrea Internationalaccessdata.fda.gov
October 3, 2013K132575PASS LP SPINAL SYSTEMOSHSubstantially EquivalentMedicrea Internationalaccessdata.fda.gov
November 21, 2011K112493PASS LP SPINAL SYSTEMMNISubstantially EquivalentMedicrea Internationalaccessdata.fda.gov
March 16, 2010K100484IMPIX MANTA CERVICAL INTERBODY DEVICEODPSubstantially EquivalentMedicreaaccessdata.fda.gov
April 9, 2008K080099PASS SPINAL SYSTEMMNISubstantially EquivalentMedicrea Technologiesaccessdata.fda.gov
October 18, 2007K070530MODIFICATION TO PASSMED SPINAL SYSTEMMNHSubstantially EquivalentMedicrea Technologiesaccessdata.fda.gov

Recalls

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

InitiatedEventClassStatusProductReasonSource
October 29, 202597996Class IIOngoingMedicrea, IB3D Universal Implant Inserter, Rx Only REF: A24000000Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant.accessdata.fda.gov
December 3, 202495957Class IIOngoingUNiD" Adaptive Spine Intelligence UNiD Spine Analyzer Product Number SW3002 UDI-DI code 03613720286929 Two cloud-based software applications within UNiD Adaptive Spine Intelligence (ASI): the UNiD HUB and the UNiD Spine Due to software anomalies that may impact on rod planning specifically, certain optional surgical parameters may have had errors that resulted i incorrect calculations displayed on system. Impacted parameters includes the following: Roussouly Classification, Real Lumbar Lordosis and Real Thoracic Kyphosis, Barrey Ratio, and Lenke Classification.accessdata.fda.gov
July 12, 202392738Class IIOngoingIMPIX 3D, REF numbers: a) B242C09122810, b) B242C10062810, c) B242C10122810, d) B242C11062810, e) B242C11122810, f) B242C12062810, g) B242C12122810, h) B242C12123310, i) B242C13062810, j) B242C13122810, k) B242C14122810,There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.accessdata.fda.gov
October 8, 202086657Class IITerminatedMEDICREA LIGAPASS TENSION PULLEY HANDLE XS- intended to provide thoracic and/or lumbar posterior stabilization for degenerative pathologies Ref : A08200200Tightening the LIGAPASS Band with this instrument, the tensioner's pliers can crush the band causing the band to break during surgery and lead to a risk of infection and re-interventionaccessdata.fda.gov
January 28, 202084928Class IITerminatedPedicle Screws, multiple sizes, Article Nos. B36004525 B36004530 B36004535 B36004540 B36004545 B36004550 B36004555 B36005530 B36005535 B36005540 B36005545 B36005550 B36005555 B36005560 B36006530 B36006535 B36006540 B3600An internal component was assembled in the incorrect orientation, which may lead to the tulip head disengaging from the crew shank during or after screw insertion, or during the reduction step.accessdata.fda.gov
November 11, 201984765Class IITerminatedMedicrea International Universal Counter Torque for use with the Pass TULIP [Spinal] System Ref : A22020500Incompatible universal counter torque (A22020500) with the nut driver T30 (A22020220)accessdata.fda.gov
October 2, 201984770Class IITerminatedMedicrea TLIF-B Holder, short intended for Intervertebral body fusion device Catalog: Number A24200010Inner draw rod, which threads into the cage may potentially be separated from the proximal knob of the inserteraccessdata.fda.gov
September 16, 201984595Class IIOngoingMedicrea Pass LP Trocar K-wire 01.6mm x 500mm-Nitinol Product reference : A06010130Conical Cannulated Screws may not accept 1.6mm K-Wire, it cannot enter the minimum tolerance axis threadedaccessdata.fda.gov
June 27, 201984273Class IITerminatedMedicrea Pass LP, REF B02217545, Non Sterile, Material: Ti-6Al-4V ELI, VIS PEDICULAIRE POLYAXIALE 7.5MM x 45MM, POLYAXIAL PEDICLE SCREW 7.5MM x 45 MM, POLYAXIAL PEDIKELSCHRAUBE 7.5MM X 45MM, TORNILLO PEDICULAR POLIAXIAL It has been determined that some Pedicle system screw identified as 45mm long have an actual length of 50mm. Pedicle screws with a diameter of 7.5 mm or more are reserved for the sacrum area. As a result, a screw that is too long could come into contact with the nerves and cause postoperative pain.accessdata.fda.gov

Compare with other makers

Updated May 15, 2026. 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.