FDA Registration
Active
🇨🇷 Costa Rica
Medtronic Medical Costa Rica S.R.L.
Reg #: 3014725904
·
FEI: 3014725904
·
Expires 2026
Products
33
Proprietary Names
152
Establishment Types
1
Classifications
33
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Registration Details
- Registration Name
- Medtronic Medical Costa Rica S.R.L.
- Registration Number
- 3014725904
- FEI Number
- 3014725904
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Coyol Free Zone Bldg B7, Multitenant 7-8, Module F
- City
- Coyol Alajuela
- Country
- CR
Regulatory Submissions
- 510(k) Number
- K201362
Owner / Operator
- Firm Name
- Medtronic, Inc.
- Operator Number
- 2112641
- Address
- 710 Medtronic Parkway
- City
- Minneapolis
- State
- MN
- Postal Code
- 55432
- Country
- US
US Agent
- Business Name
- MEDTRONIC INC.
- Contact Name
- Michelle Obenauer
- Address
- Medtronic Sofamor Danek Headquarters, 1800 Pyramid Place
- City
- Memphis
- State
- TN
- ZIP
- 38132
- Country
- US
- [email protected]
- Phone
- 901 3992117
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2020-10-06 |
| Cement, Bone, Vertebroplasty | NDN | Class 2 | Orthopedic | No | 2020-10-06 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2020-10-06 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2020-10-06 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2020-10-06 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2020-10-06 |
| Bone Cement, Posterior Screw Augmentation | PML | Class 2 | Orthopedic | No | 2020-10-06 |
| Sacroiliac Joint Fixation | OUR | Class 2 | Orthopedic | No | 2016-10-17 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2008-01-30 |
| Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | OSH | Class 2 | Orthopedic | No | 2015-02-12 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2015-02-12 |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2023-07-17 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2023-06-23 |
| Spinal Vertebral Body Replacement Device | MQP | Class 2 | Orthopedic | No | 2022-11-03 |
| Orthosis, Spine, Plate, Laminoplasty, Metal | NQW | Class 2 | Orthopedic | No | 2007-03-08 |
| Posterior Metal/Polymer Spinal System, Fusion | NQP | Class 2 | Orthopedic | No | 2008-01-31 |
| Posterior Cervical Screw System | NKG | Class 2 | Orthopedic | No | 2020-03-31 |
| Wire, Surgical | LRN | Class 2 | Orthopedic | No | 2008-02-05 |
| Dispenser, Cement | KIH | Class 1 | Orthopedic | No | 2008-02-27 |
| Mesh, Surgical, Metal | EZX | Class 2 | General, Plastic Surgery | No | 2023-07-27 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2006-06-29 |
| Accessories, Arthroscopic | NBH | Class 1 | Orthopedic | No | 2005-03-23 |
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2008-02-05 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2006-06-29 |
| System, Facet Screw Spinal Device | MRW | Class U | Unknown | No | 2008-02-04 |
| Growing Rod System | PGM | Class 2 | Orthopedic | No | 2015-12-08 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | Class 2 | Orthopedic | No | 2023-07-17 |
| Template | HWT | Class 1 | Orthopedic | No | 2006-05-17 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2008-02-04 |
| Light, Surgical, Carrier | FSZ | Class 2 | General, Plastic Surgery | No | 2008-02-04 |
| Drills, Burrs, Trephines & Accessories (Simple, Powered) | HBE | Class 2 | Neurology | No | 2015-04-01 |
| Cutter, Surgical | FZT | Class 1 | General, Plastic Surgery | No | 2021-09-09 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2014-08-10 |
Proprietary Names
CD HORIZON® Fenestrated Screw Set
RIALTO SI Fusion System
Vertex Keel Plate
CD HORIZON ESSENTIALS Spinal System
CD HORIZON ESSENCE
TSRH Spinal system Crosslink Plates
Spinal System
TSRH
CD Horizon Advanta
CD Spinal System
MSB PYRAMESH® Implant System
CD Horizon 3.5 Rods
ZEVO Anterior Cervical Plate System
CD Horizon-Spinal System/ CD Horizon SOLERA
CD HORIZON Spinal System
SPINE
PLATE
LAMINOPLASTY
CD Horizon Spinous Plate
CD HORIZON® Spinal System
CD Cannulated Screw
DIVERGENCE-L" ANTERIOR/OBLIQUE LUMBAR FUSION SYSTEM
CD Horizan Spinal Ti Spinal System
Vantage Bolts
TSRH Chromaloy Plus Precut Contoured Rods
TSRH Osteogrip
CD 4.5 Crosslink Plates
Pyramid +4 Anterior Lumbar Plate
VERTEX® Reconstruction System
TENOR Spinal System
MODIFICATION TO TENOR SPINAL SYSTEM-PLATES
CD Horizon Spinal System
CRESCENT SPINAL SYSTEM TITANIUM
ELEVATE SPINAL SYSTEM
CRESCENT SPINAL SYSTEM
CAPSTONE PTC SPINAL SYSTEM
TSRH TC 3D MPA Screw
CD Horizan M8 Screws
Vantage Plates
Vertex Reconstruction System
CD HORIZON(R) Spinal System
CD Spire Spikes
Catalyft PL Expandable Interbody System
TSRH Spinal System
TSRH Expanded Pedicle Screw
Vertex Lateral Connectors
TSRH TC Splined Connectors & Screws
Atlas Cable
Pyramesh
KYPHON Cement Delivery System
KyphX Bone Filler Device
TSRH Cobalt Chrome Rods
CD HorizonSpinal System
CD Perc Trauma
CD Staples and Screws
Vertex Crosslinks
MULTIPLE TWIST
Drill; Introducer Tool
MICRO-FRANCE
BIT DRILLS
DRILL BIT (ORTHOPEDIC MA
ARTHROSCOPE
ELEVATE" Spinal System
CD Horizon Legacy 4.5
PYRAMID +4 Anterior Lumbar Plate S
METRx Endoscope
CD HORIZON Spinal System SDS Pre-Bent Rods
General Instrument
PASS LP Spinal System
ZPlate II
Townley Transfacetpedicular Screw
Pyramesh Implant System
NAVIGATED INFINITY Instruments
CD HORIZON Growth Rod Conversion Set
CD HORIZON SOLERA Spinal System
TSRH Spinal System Prebent/precut r
Atlantis Translational Plate
SOVEREIGN Spinal System
CD HORIZON Solera 5.5/6
CD HORIZON® SOLERA® Spinal System
Tenor Spinal System
CD Horizon Set Screws
CD Horizan Eclipse M8 Screws
TEMPLATE
VERTEX
CD HORIZON Fenestrated Screw Set
Kyphon HV-R Fenestrated Screw Cement
Vertex Adjustable Plate
TSRH Hook Holder
CD HORIZON Spinal System SOLERA
Atlantis Vision Anterior Cervical
CD Horizon Eclipse
MAST QUADRANT Retractor System
Pyramesh C
Vertex Max
Vertex Occipital Components
CCD Spine System
CD Horizon M8 M10 Reduction Hooks
TSRH 3Dx 90 Degree Offset Connector
INFINITY OCT System
Multi Axial Screw System
CD Horizon- Spinal System
VERTEX Reconstruction System
PIVOX" Oblique Lateral Spinal System
Vertex OC MAS, Rods, Hooks
CD 5.5mm Set Screws
Vertex Reconstruction Occipital
CD Horizon MAS Design Enhancement
CDH Solera 4.75
CD HORIZON SOLERA"
Orfil Spine Fixation system
CD Horizon Antares Spinal System
VENTURE Anterior Cervical Plate System
Venture Cervical Plate
CD Cobalt Chrome
CD Horizon ModuLeX Spinal System
Peek Rod
TENOR SPINAL SYSDYNA-LOK PLUS Plate
Equation Fixation System
Navigated Vertex Select Drill Bit
Navigated Vertex Select Threaded Driver
Navigated Vertex Select Tap
Thoracolumbosacral pedicle screw system
CD HORIZON SPINAL SYSTEM
CD Horizon® Spinal System
CD HORIZON SOLERA SPINAL SYSTEM
TSRH TC Threaded Screws
CD Horizon Legacy 6.35 Ti
CD Horizon 3.2/4.5 Connectors
Vertex Cannulated Screw
TSRH Crosslink System
CD HORIZONSPINAL SYSTEM
CD HORIZONSpinal System
Bone Graft Washer
CD HORIZON Longitude 2 Instruments and Rods
CD Ilio Sacral Screws
General Instruments
Danek Precision Rod Set
DIVERGENCE(TM) Anterior Cervical Fusion System
CDH Legacy 5.5
TSRH Sentry Anterior/Posterior Spin
CD Horizon 6.35 Crosslink Plates
RETRACTOR
RadiaLux
Spacekeeper
TSRH Silo
CD Horizon Ilio Sacral
Sovereign
Titanium GDLH Posterior Spinal Syst
TSRH 3D Connectors
CD HORIZON Spinal System
TSRH Spinal System MPA Screws
Establishment Types
Manufacture Medical Device