MEDICREA INTERNATIONAL

FDA Device Registration & Listing · RILLIEUX-LA-PAPE Auvergne-Rhone-Alpes, FR · Registration 1000432246

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1000432246
FEI Number
1000432246
Entity Name
MEDICREA INTERNATIONAL
City/State/Country
RILLIEUX-LA-PAPE Auvergne-Rhone-Alpes, FR
Establishment Address
5389 route de Strasbourg - Vancia, RILLIEUX-LA-PAPE Auvergne-Rhone-Alpes 69140, FR
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Medtronic, Inc. (Owner Number: 2112641)
Owner / Operator Contact Address
710 Medtronic Parkway, Minneapolis, MN 55432, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K182240
PMA Number
N/A

All Registered Proprietary Names

PASS LP SPINAL SYSTEM PASS LP PASS LP SPINAL SYSTEM BONE TAP Tray, Surgical, Instrument instrument tray Aspen Bard-Parker Wire Nest PROBE (ORTHOPEDIC MANU CD Horizon™ ModuLeX™ Spinal System PASS LP SPINAL SYSTEM LIGAPASS IMPIX 3D Print LIGAPASS SCREWDRIVER MULTIPLE (DEPTH GAUGES) MULTIPLE (ORTHOPEDIC REAMERS) SPATULA, ORTHOPEDIC MODIFICATION TO PASSMED SPINAL SYSTEM Medtronic General Instrument UNiD™ Calibration Sphere UNiD™ Spine Analyzer MULTIPLE (DRIVER-EXTRACTORS) IB3D™ PL Spinal System UNiD™ Spine analyzer TEMPLATE RONGEUR General Instrument PASS LP Spinal System IB3D™ PL Spinal System PASS LP SPINAL SYSTEM PASS OCT Patient Specific Rods Medtronic Reusable Instrument IB3D™ PL Spinal System UNiD™ LIGAPASS C-Curve Medtronic Reusable Instrument PASS LP SPINAL SYSTEM PASS LP PASS TULIP

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2021-10-25
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2021-10-25
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2021-10-25
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2021-10-25
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2019-05-03
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2019-05-03
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2021-10-27
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2021-10-27
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2021-10-27
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2021-10-27
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2021-10-27
HWX Tap, Bone Orthopedic Class 1 888.4540 1978-02-15
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2001-03-30
HXB Probe Orthopedic Class 1 888.4540 2006-06-29
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2021-10-25
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2021-10-25
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2021-10-25
OWI Bone Fixation Cerclage, Sublaminar Orthopedic Class 2 888.3010 2014-01-29
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2017-12-05
OWI Bone Fixation Cerclage, Sublaminar Orthopedic Class 2 888.3010 2018-04-16
HXX Screwdriver Orthopedic Class 1 888.4540 1992-12-12
HTJ Gauge, Depth Orthopedic Class 1 888.4300 2005-05-31
HTO Reamer Orthopedic Class 1 888.4540 2005-05-31
HXR Spatula, Orthopedic General, Plastic Surgery Class 1 878.4800 2021-10-25
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2021-10-20
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2021-10-20
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2021-10-20
HXG Tamp Orthopedic Class 1 888.4540 2004-08-18
JAC System, X-Ray, Film Marking, Radiographic Radiology Class 1 892.1640 2022-09-09
QIH Automated Radiological Image Processing Software Radiology Class 2 892.2050 2025-09-23
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2025-09-23
HWB Extractor Orthopedic Class 1 888.4540 2005-05-31
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2026-05-27
QIH Automated Radiological Image Processing Software Radiology Class 2 892.2050 2026-05-27
HWT Template Orthopedic Class 1 888.4800 2006-05-17
HTZ Instrument, Cutting, Orthopedic General, Plastic Surgery Class 1 878.4800 2005-05-31
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2006-06-29
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2024-09-25
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2021-10-20
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2021-10-20
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2021-10-20
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2021-10-20
NKG Posterior Cervical Screw System Orthopedic Class 2 888.3075 2021-10-27
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2021-10-27
HWA Impactor Orthopedic Class 1 888.4540 2002-11-19
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2022-05-04
OWI Bone Fixation Cerclage, Sublaminar Orthopedic Class 2 888.3010 2017-09-18
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2021-10-05
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2021-10-05
HXW Bender Orthopedic Class 1 888.4540 1992-12-12
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2021-10-27
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2021-10-27
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2021-10-27
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2021-10-27
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2021-10-27
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2018-10-25
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2018-10-25

Official Correspondent

No official correspondent registered.

US Agent Details

Alison Webster Email: alison.s.webster@medtronic.com Phone: (901) 3992384

Related Public Records

Same Entity

Medtronic, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3007042319 HeartWare, Inc. Miami Lakes, FL, US
3004497303 MEDTRONIC MEXICO EG EMPALME Sonora, MX
3015192387 CATHWORKS Newport Beach, CA, US
3004185781 Medtronic, Inc. Tempe, AZ, US
3012520654 MEDTRONIC, INC. Billerica, MA, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K103464 Medtronic, Inc. PACIFIC XTREME PTCA BALLOON DILATATION CATHETER 2010-12-22
K111339 Medtronic, Inc. HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS) 2011-06-08
K963639 Acromed Corp. ACROMED PEDICLE SCREW 1996-11-14
K032604 Co-Ligne AG GII SPINAL FIXATION SYSTEM 2004-01-20
K964304 Osteonics Corp. OSTEONICS SPINAL SYSTEM-TOPLOADING TRANSVERSE CONNECTOR ASSEMBLY 1997-01-17

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0026-2011 Zimmer Inc. 2
SpeedLink 5.5 Transverse Connector Short 39.5-44mm, non-sterile, 1302-55S
Z-0027-2011 Zimmer Inc. 2
SpeedLink 5.5 Transverse Connector Medium 43-51mm, non-sterile, 1302-55M
Z-0028-2011 Zimmer Inc. 2
SpeedLink 5.5 Transverse Connector Long 50-65mm, non-sterile, 1302-55L
Z-0029-2011 Zimmer Inc. 2
SpeedLink 5.5 Transverse Connector X-Long 60-75mm, non-sterile, 1302-55XL
Z-0030-2011 Zimmer Inc. 2
SpeedLink 6.0 Transverse Connector Short 39.5-44mm, non-sterile, 1304-60S

Similar Registrations

Registration Number Establishment Name Location
3009941480 LISI MEDICAL REmmele Big Lake, MN, US
3004635447 C&W SWISS, INC. CLAYTON, OH, US
3015869493 Jabil Switzerland Manufacturing GmbH (Mezzovico) Mezzovico Ticino, CH
3016050940 Olive Branch Distribution Center Olive Branch, MS, US
3009417901 SYNTHES GMBH Zuchwil Solothurn, CH
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1000432246. Last updated year: 2026. Please use registration number 1000432246 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.