FDA Registration
Active
🇫🇷 France
MEDICREA INTERNATIONAL
Reg #: 1000432246
·
FEI: 1000432246
·
Expires 2026
Products
31
Proprietary Names
48
Establishment Types
2
Classifications
31
Registration Details
- Registration Name
- MEDICREA INTERNATIONAL
- Registration Number
- 1000432246
- FEI Number
- 1000432246
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 5389 route de Strasbourg - Vancia
- City
- RILLIEUX-LA-PAPE Auvergne-Rhone-Alpes
- Country
- FR
Regulatory Submissions
- 510(k) Number
- K132574
Owner / Operator
- Firm Name
- Medtronic, Inc.
- Operator Number
- 2112641
- Address
- 710 Medtronic Parkway
- City
- Minneapolis
- State
- MN
- Postal Code
- 55432
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2021-10-25 |
| Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | OSH | Class 2 | Orthopedic | No | 2021-10-25 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2021-10-25 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2021-10-25 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2019-05-03 |
| Tap, Bone | HWX | Class 1 | Orthopedic | No | 1978-02-15 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2001-03-30 |
| Probe | HXB | Class 1 | Orthopedic | No | 2006-06-29 |
| Bone Fixation Cerclage, Sublaminar | OWI | Class 2 | Orthopedic | No | 2014-01-29 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2017-12-05 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 1992-12-12 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2005-05-31 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2005-05-31 |
| Spatula, Orthopedic | HXR | Class 1 | General, Plastic Surgery | No | 2021-10-25 |
| Tamp | HXG | Class 1 | Orthopedic | No | 2004-08-18 |
| System, X-Ray, Film Marking, Radiographic | JAC | Class 1 | Radiology | No | 2022-09-09 |
| Automated Radiological Image Processing Software | QIH | Class 2 | Radiology | No | 2025-09-23 |
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2025-09-23 |
| Extractor | HWB | Class 1 | Orthopedic | No | 2005-05-31 |
| Template | HWT | Class 1 | Orthopedic | No | 2006-05-17 |
| Instrument, Cutting, Orthopedic | HTZ | Class 1 | General, Plastic Surgery | No | 2005-05-31 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2006-06-29 |
| Posterior Cervical Screw System | NKG | Class 2 | Orthopedic | No | 2021-10-27 |
| Impactor | HWA | Class 1 | Orthopedic | No | 2002-11-19 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2021-10-05 |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | Class 2 | Orthopedic | No | 2021-10-05 |
| Bender | HXW | Class 1 | Orthopedic | No | 1992-12-12 |
| Wrench | HXC | Class 1 | Orthopedic | No | 1992-12-12 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2006-06-29 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2022-01-11 |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2021-10-27 |
Proprietary Names
PASS LP SPINAL SYSTEM
PASS LP
BONE TAP
Tray, Surgical, Instrument
instrument tray
Aspen
Bard-Parker
Wire Nest
PROBE (ORTHOPEDIC MANU
CD Horizon ModuLeX Spinal System
LIGAPASS
IMPIX 3D Print
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
PASS OCT Patient Specific Rods
Medtronic Reusable Instrument
UNiD
C-Curve
PASS TULIP
WRENCH
Orthopedic manual surgical instrument
Infinity OCT System And PASS OCT Spinal System
IMPIX MANTA CERVICAL INTERBODY DEVICE
PASS OCT SPINAL SYSTEM
MULTIPLE TWIST
Drill; Introducer Tool
MICRO-FRANCE
BIT DRILLS
DRILL BIT (ORTHOPEDIC MA
CD Horizon Spinal System
PASS LP Spinal System
PASS TL
IMPIX ALIF S/A
PASS SPINAL SYSTEM
CD Horizon Spinal System and PASS LP Spinal System
Establishment Types
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility