FDA Registration
Active
🇺🇸 United States
MEDTRONIC PUERTO RICO OPERATIONS CO., HUMACAO
Reg #: 2647346
·
FEI: 2647346
·
Expires 2026
Products
45
Proprietary Names
231
Establishment Types
1
Classifications
45
Registration Details
- Registration Name
- MEDTRONIC PUERTO RICO OPERATIONS CO., HUMACAO
- Registration Number
- 2647346
- FEI Number
- 2647346
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- ROAD 909, KM. 0.4., BARRIO MARIANA
- City
- HUMACAO
- State
- PR
- ZIP
- 00792
- Country
- US
Regulatory Submissions
- 510(k) Number
- K042789
- PMA Number
- P000058
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 |
|---|---|---|---|---|---|
| Instrument, Bending Or Contouring | HXP | Class 1 | Orthopedic | No | 1992-12-12 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2008-01-30 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2008-01-31 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2008-01-31 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2008-01-31 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2008-01-31 |
| Posterior Metal/Polymer Spinal System, Fusion | NQP | Class 2 | Orthopedic | No | 2008-01-31 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2008-02-04 |
| Light, Surgical, Carrier | FSZ | Class 2 | General, Plastic Surgery | No | 2008-02-04 |
| Accessories, Arthroscopic | NBH | Class 1 | Orthopedic | No | 2008-02-04 |
| Spinal Vertebral Body Replacement Device | MQP | Class 2 | Orthopedic | No | 2008-02-01 |
| System, Facet Screw Spinal Device | MRW | Class U | Unknown | No | 2008-02-04 |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | Class 2 | Orthopedic | No | 2015-02-03 |
| Sacroiliac Joint Fixation | OUR | Class 2 | Orthopedic | No | 2016-02-26 |
| Orthosis, Spine, Plate, Laminoplasty, Metal | NQW | Class 2 | Orthopedic | No | 2021-12-15 |
| Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | OSH | Class 2 | Orthopedic | No | 2012-10-12 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2010-07-28 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2016-10-17 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2016-10-17 |
| Drills, Burrs, Trephines & Accessories (Simple, Powered) | HBE | Class 2 | Neurology | No | 2021-06-24 |
| Wire, Surgical | LRN | Class 2 | Orthopedic | No | 2008-02-05 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2010-07-28 |
| Wrench | HXC | Class 1 | Orthopedic | No | 1992-12-12 |
| Template | HWT | Class 1 | Orthopedic | No | 2006-05-17 |
| Growing Rod System | PGM | Class 2 | Orthopedic | No | 2015-12-08 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2007-12-10 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2007-12-10 |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2016-01-14 |
| Bender | HXW | Class 1 | Orthopedic | No | 1992-12-12 |
| Cement, Bone, Vertebroplasty | NDN | Class 2 | Orthopedic | No | 2020-10-06 |
| Bone Cement, Posterior Screw Augmentation | PML | Class 2 | Orthopedic | No | 2020-10-06 |
| Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction | NEK | Class 3 | Unknown | No | 2008-03-31 |
| Cutter, Surgical | FZT | Class 1 | General, Plastic Surgery | No | 2021-09-09 |
| Motor, Drill, Pneumatic | HBB | Class 2 | Neurology | No | 2007-12-20 |
| Dispenser, Cement | KIH | Class 1 | Orthopedic | No | 2008-02-27 |
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2008-02-05 |
| Posterior Cervical Screw System | NKG | Class 2 | Orthopedic | No | 2026-02-03 |
| Filler, Bone Void, Calcium Compound | MQV | Class 2 | Orthopedic | No | 2008-02-06 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2006-06-29 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2006-06-29 |
| Mesh, Surgical, Metal | EZX | Class 2 | General, Plastic Surgery | No | 2008-02-01 |
| Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | ERL | Class 2 | Ear, Nose, Throat | No | 2019-05-22 |
| Motor, Drill, Electric | HBC | Class 2 | Neurology | No | 2019-05-22 |
| Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment | HSZ | Class 1 | General, Plastic Surgery | No | 2019-05-22 |
| Prosthesis, Intervertebral Disc | MJO | Class 3 | Unknown | No | 2014-09-12 |
Proprietary Names
ROD BENDER
Vertex Max
CD Horizon 3.2/4.5 Connectors
CD Modified Set Screws
CD HORIZON® Spinal System
Thoracolumbosacral pedicle screw system
MAST QUADRANT Retractor System
Vertex Reconstruction System
Verte-Stack Capstone Peek
TSRH Spinal System Anterior L Plate
CD HORIZON SPINAL SYSTEM
CD Horizon Spinous Plate
CD Horizon 6.35 Crosslink Plates
TSRH 3Dx 90 Degree Offset Connector
Townley Transfacetpedicular Screw
CD 4.5 Crosslink Plates
DIVERGENCE Anterior Cervical Fusion System
Verte-Stack T-Peek
RIALTO" SI FUSION SYSTEM
Centerpiece Plate Fixation System
CD Horizon Solera HA Screws
CD HORIZON SOLERA Spinal System
CD HORIZON Spinal System
ORION Anterior Cervical
ANTERIOR CERVICAL PLATE SYSTEM
Vertex Occipital Components
Townley Pedicle Screw
Dyna-Lok Ti Spinal System
CD Horizon Eclipse
CORNERSTONEPSR Spinal System
CD Horizon Spinal System
T2 Sinal System
RIALTO SI Fusion System
CD Horizon ModuLeX Spinal System
Vertex OC MAS, Rods, Hooks
CD HORIZONSpinal System
Vertex Cannulated Screw
TSRH TC Splined Connectors & Screws
TSRH Spinal system Crosslink Plates
CD 5.5mm Set Screws
Atlas Cable
CD Horizon Astute Spinal System
Zephir Anterior Cervical Plate
CORNERSTONE PSR Cervical Fusion System
CD HORIZON(R) Spinal System
TSRH
CD Ilio Sacral Screws
Clydesdale Spinal System
CD Horizon MAS Design Enhancement
TSRH TC 3D MPA Screw
TSRH Spinal System
WRENCH
Vertex Crosslinks
CD HORIZON
CD Horizon Legacy 6.35 Ti
Verte-Stack XS
COLORADO II Spinal System SS
TEMPLATE
Verte-Stack Perimeter Peek
TSRH Crosslink System
Dyna-Lok Plate and Screw
CDH Legacy 5.5
CD Perc Trauma
Verte-Stack Crescent
VERTEX® Reconstruction System
CD Spire Spikes
VERTEX SELECT Reconstruction System
spinal system
CD Cobalt Chrome
Premier Anterior Cervical Plate
Multi Axial Screw System
TSRH Chromaloy Plus Precut Contoured Rods
CD Horizon Spinal System
Pyramid +4 Anterior Lumbar Plate
Vantage Bolts
Galaky Spinal system
CD HORIZON Growth Rod Conversion Set
VENTURE Anterior Cervical Plate System
CD Horizon Modular 5.5/6mm Spinal System
CD Horizon Set Screws
TSRH 3D Connectors
TENOR SPINAL SYSDYNA-LOK PLUS Plate
PYRAMID +4 Anterior Lumbar Plate S
ATLANTIS Anterior Cervical Plate System, ATLANTIS ESSENTIALS" Anterior Cervical Plate System
Timesh System
PIVOX" Oblique Lateral Spinal System
ZPlate II
CD Horizon ModuLeX Spinal System - Degen Scoli Phase 2
Medtronic Reusable Instrument
PERIMETER Interbody Fusion Device
Crescent Spinal System Interbody F
CCD Spine System
CD HORIZON Solera 5.5/6
CD HORIZON® Fenestrated Screw Set
CD Horizon 3.5 Rods
VERTEX
Navigated Vertex Select Drill Bit
Navigated Vertex Select Threaded Driver
Navigated Vertex Select Tap
Vertex Reconstruction Occipital
CD HORIZON® SOLERA® Spinal System
CD Horizon TAH Pedicle Hooks
INFUSE BONEGRAFT/ LT-CAGE Lumbar TF
CD HORIZON Multiaxial screw
CAPSTONE PTC SPINAL SYSTEM
CD Central Rod
COLORADO 2 Spinal System
General Instruments
CD Horizan Eclipse M8 Screws
TSRH Spinal System MPA Screws
CD Horizon- Spinal System
PEEK Previal Cervical Interbody Dev
COLORADO II Spinal System Ti
VERTEX Reconstruction System
CD HORIZONSPINAL SYSTEM
Venture Cervical Plate
CD HorizonSpinal System
Midas Rex Legend Pneumatic System
ACPii Atlantis Cervial Plate
Pyramesh C
CD Horizon Ilio Sacral
KYPHON Cement Delivery System
KyphX Bone Filler Device
Verte-Stack Cornerstone Sm End Caps
DIVERGENCE(TM) Anterior Cervical Fusion System
METRx Microscope
Capstone Control
Orfil Spine Fixation system
Verte-Stack Modified Cornerstone
TSRH Expanded Pedicle Screw
CD HORIZON Spinal System
CD HA Coated
NAVIGATED INFINITY Instruments
TSRH Sentry Anterior/Posterior Spin
Sovereign
CD HORIZON Spinal System, CD HORIZON ESSENTIALS" Spinal System
MSB PYRAMESH® Implant System
INFINITY Occipitocervical Upper Thoracic System
Transverse Oct Spinal Fixation
DIVERGENCE-L" ANTERIOR/OBLIQUE LUMBAR FUSION SYSTEM
CAPSTONE Spinal System
Vertex Lateral Connectors
MASTERGRAFT PUTTY
COLORADO 2 Spinal Sys 6.35 Rods and
Tenor Spinal System
TSRH Spinal System Prebent/precut r
CD HORIZON Longitude 2 Instruments and Rods
Danek Unit Rod
CEMENT
VERTEBROPLASTY
SOVEREIGN Spinal System
CD Horizon-Spinal System/ CD Horizon SOLERA
Spinal System
Vertex Adjustable Plate
Orion Anterior Cervical Plate
CD Cannulated Screw
Verte-Stack Modified Center Piece
PEEK Prevail Cervical Interbody Dev
ARTHROSCOPE
Atlantis Vision Anterior Cervical
CD Horizon ModuLeX Fenestrated Screw Set
RETRACTOR
RadiaLux
Spacekeeper
TSRH Osteogrip
ATLANTIS- Anterior Cervical Plate System
General Instrument
PASS LP Spinal System
Zephir Anterior Cervical Plate System
CD HORIZON Spinal System SOLERA
CD HORIZON SOLERA SPINAL SYSTEM
TSRH Hook Holder
CD Horizon Minor Mod
CD Horizon Advanta
T2 TXVBR
CAPSTONE CONTROL Spinal System
CAPSTONE CONTROL PTC Spinal System
Transverse Spinal Fixation
TSRH Silo
MULTIPLE TWIST
Drill; Introducer Tool
MICRO-FRANCE
BIT DRILLS
DRILL BIT (ORTHOPEDIC MA
Pyramesh Implant System
Atlantis Translational Plate
ELEVATE" Spinal System
Legacy 6.35 SS
CD HORIZON ESSENTIALS Spinal System
CD HORIZON ESSENCE
CD Staples and Screws
CRESCENT SPINAL SYSTEM TITANIUM
ELEVATE SPINAL SYSTEM
CRESCENT SPINAL SYSTEM
CAPSTONE PTC SPINAL SYSTEM
CLYDESDALE Spinal System
Peek Rod
Vantage Plates
Titanium GDLH Posterior Spinal Syst
ZEVO Anterior Cervical Plate System
CD HORIZON Spinal System SDS Pre-Bent Rods
Catalyft PL Expandable Interbody System
TSRH CROSSLINK Axial and Offset Pl
CD HORIZON SPIRE(TM) Z Spinal System
CD Horizon Antares Spinal System
CD Horizon® Spinal System
Bone Graft Washer
Vertex Keel Plate
mastergraft
CD Horizon M8 M10 Reduction Hooks
CD Horizon ModuLeX FNS Screw Set
CD Horizan M8 Screws
UCSS Non-Cannulated
TSRH Cobalt Chrome Rods
SPINE
PLATE
LAMINOPLASTY
METRx Endoscope
Capstone Spinal System
CD HORIZON Fenestrated Screw Set
Kyphon HV-R Fenestrated Screw Cement
CD Horizon Solera 5.5/6 Sagittal Adjusting Screws
CDH Solera 4.75
CD HORIZON SOLERA"
Dyan-Lok Anterior Posterior Plating
CD Horizon Legacy 4.5
MR8 Drill System
Midas Rex MR8 ClearView Tools
TSRH Spinal System 3D Connectors an
INFINITY OCT System
PRESTIGE LP Cervical Disc System
Establishment Types
Manufacture Medical Device