FDA Registration
Active
🇺🇸 United States
Jabil Inc. (Monument)
Reg #: 3015399803
·
FEI: 3015399803
·
Expires 2026
Products
95
Proprietary Names
97
Establishment Types
1
Classifications
95
Registration Details
- Registration Name
- Jabil Inc. (Monument)
- Registration Number
- 3015399803
- FEI Number
- 3015399803
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1051 Synthes Avenue
- City
- Monument
- State
- CO
- ZIP
- 80132
- Country
- US
Owner / Operator
- Firm Name
- Jabil Inc.
- Operator Number
- 9074019
- Address
- 10800 Roosevelt Blvd.
- City
- Saint Petersburg
- State
- FL
- Postal Code
- 33716
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2019-05-01 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2019-04-28 |
| Template | HWT | Class 1 | Orthopedic | No | 2019-04-29 |
| Screw, Fixation, Intraosseous | DZL | Class 2 | Dental | No | 2019-05-01 |
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2019-05-01 |
| Plate, Bone | JEY | Class 2 | Dental | No | 2019-04-30 |
| Spinal Vertebral Body Replacement Device | MQP | Class 2 | Orthopedic | No | 2019-05-02 |
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2019-05-02 |
| Cement, Bone, Vertebroplasty | NDN | Class 2 | Orthopedic | No | 2019-05-02 |
| Curette | HTF | Class 1 | General, Plastic Surgery | No | 2019-04-26 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2019-04-29 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2019-05-01 |
| Cerclage, Fixation | JDQ | Class 2 | Orthopedic | No | 2019-05-01 |
| Elevator | HTE | Class 1 | General, Plastic Surgery | No | 2019-04-29 |
| External Mandibular Fixator And/Or Distractor | MQN | Class 2 | Dental | No | 2019-04-29 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2018-08-10 |
| Awl | HWJ | Class 1 | Orthopedic | No | 2019-04-29 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2015-01-15 |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | Class 2 | Orthopedic | No | 2019-04-29 |
| Forceps, General & Plastic Surgery | GEN | Class 1 | General, Plastic Surgery | No | 2019-04-29 |
| Blade, Saw, General & Plastic Surgery, Surgical | GFA | Class 1 | General, Plastic Surgery | No | 2018-08-10 |
| Neurological Stereotaxic Instrument | HAW | Class 2 | Neurology | No | 2019-05-02 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2019-05-02 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | Class 2 | Orthopedic | No | 2019-04-28 |
| Spinal Channeling Instrument, Vertebroplasty | OCJ | Class 1 | Orthopedic | No | 2019-05-02 |
| Implant, Fixation Device, Spinal | JDN | Class 2 | Orthopedic | No | 2019-04-29 |
| Pin, Fixation, Smooth | HTY | Class 2 | Orthopedic | No | 2019-04-29 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2019-04-29 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2019-04-29 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2019-04-29 |
| Pin, Fixation, Threaded | JDW | Class 2 | Orthopedic | No | 2019-04-28 |
| Plate, Cranioplasty, Preformed, Non-Alterable | GXN | Class 2 | Neurology | No | 2019-04-29 |
| Nail, Fixation, Bone | JDS | Class 2 | Orthopedic | No | 2019-05-01 |
| Cutter, Surgical | FZT | Class 1 | General, Plastic Surgery | No | 2019-04-29 |
| Washer, Bolt Nut | HTN | Class 2 | Orthopedic | No | 2019-05-01 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2019-04-29 |
| Dispenser, Cement | KIH | Class 1 | Orthopedic | No | 2019-05-01 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2019-05-02 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Single Component | KTW | Class 2 | Orthopedic | No | 2024-08-01 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite | LXT | Class 2 | Orthopedic | No | 2024-08-01 |
| Drills, Burrs, Trephines & Accessories (Manual) | HBG | Class 2 | Neurology | No | 2019-05-02 |
| Posterior Cervical Screw System | NKG | Class 2 | Orthopedic | No | 2019-04-29 |
| Condylar Plate Fixation Implant | JDP | Class 2 | Orthopedic | No | 2019-04-30 |
| Motor, Surgical Instrument, Ac-Powered | GEY | Class 1 | General, Plastic Surgery | No | 2019-05-01 |
| Bender | HXW | Class 1 | Orthopedic | No | 2019-04-29 |
| Starter, Bone Screw | HWD | Class 1 | Orthopedic | No | 2019-05-01 |
| Prosthesis, Elbow, Hemi-, Radial, Polymer | KWI | Class 2 | Orthopedic | No | 2019-05-02 |
| Extractor | HWB | Class 1 | Orthopedic | No | 2019-03-08 |
| Device, Percutaneous, Biopsy | MJG | Class 1 | General, Plastic Surgery | No | 2019-05-02 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2019-04-29 |
| Probe | HXB | Class 1 | Orthopedic | No | 2019-04-29 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2019-04-29 |
| Bone Cement | LOD | Class 2 | Orthopedic | No | 2019-05-02 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2019-03-08 |
| Single Use Instrument Tray | OJV | Class 1 | General, Plastic Surgery | No | 2019-05-02 |
| Implant, Endosseous, Orthodontic | OAT | Class 2 | Dental | No | 2019-04-30 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2019-04-29 |
| Fastener, Plate, Cranioplasty | HBW | Class 2 | Neurology | No | 2019-04-28 |
| Instrument, Bending Or Contouring | HXP | Class 1 | Orthopedic | No | 2019-04-29 |
| Instrument, Compression | HWN | Class 1 | Orthopedic | No | 2019-05-02 |
| Battery, Replacement, Rechargeable | MOQ | Class 1 | General, Plastic Surgery | No | 2019-05-01 |
| Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile | GAQ | Class 2 | General, Plastic Surgery | No | 2019-04-29 |
| Impactor | HWA | Class 1 | Orthopedic | No | 2019-04-29 |
| Clamp | HXD | Class 1 | General, Plastic Surgery | No | 2019-04-28 |
| Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | ERL | Class 2 | Ear, Nose, Throat | No | 2019-04-29 |
| Drill, Bone, Powered | DZI | Class 2 | Dental | No | 2019-04-29 |
| Drills, Burrs, Trephines & Accessories (Simple, Powered) | HBE | Class 2 | Neurology | No | 2019-04-29 |
| Apparatus, Traction, Non-Powered | HST | Class 1 | Orthopedic | No | 2019-04-29 |
| Tamp | HXG | Class 1 | Orthopedic | No | 2019-04-29 |
| Pliers, Surgical | HTC | Class 1 | General, Plastic Surgery | No | 2019-04-29 |
| Cannula, Surgical, General & Plastic Surgery | GEA | Class 1 | General, Plastic Surgery | No | 2019-03-04 |
| Bur, Surgical, General & Plastic Surgery | GFF | Class 1 | General, Plastic Surgery | No | 2019-05-01 |
| Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment | HSZ | Class 1 | General, Plastic Surgery | No | 2019-05-01 |
| Wrench | HXC | Class 1 | Orthopedic | No | 2019-04-29 |
| Orthosis, Spine, Plate, Laminoplasty, Metal | NQW | Class 2 | Orthopedic | No | 2019-04-30 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2018-08-10 |
| Cover, Burr Hole | GXR | Class 2 | Neurology | No | 2019-05-02 |
| Plate, Cranioplasty, Preformed, Alterable | GWO | Class 2 | Neurology | No | 2019-05-02 |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2019-04-29 |
| Bit, Surgical | GFG | Class 1 | General, Plastic Surgery | No | 2019-04-29 |
| Retractor, Fiberoptic | FDG | Class 1 | Gastroenterology, Urology | No | 2018-08-10 |
| Pusher, Socket | HXO | Class 1 | Orthopedic | No | 2019-04-28 |
| Sacroiliac Joint Fixation | OUR | Class 2 | Orthopedic | No | 2019-05-01 |
| Prosthesis, Condyle, Mandibular, Temporary | NEI | Class 2 | Dental | No | 2024-08-01 |
| Wire, Fixation, Intraosseous | DZK | Class 2 | Dental | No | 2024-08-01 |
| Washer, Bolt, Nut, Non-Spinal, Metallic | NDG | Class 2 | Orthopedic | No | 2024-08-01 |
| Accessories, Arthroscopic | NBH | Class 1 | Orthopedic | No | 2019-05-01 |
| Injector, Vertebroplasty (Does Not Contain Cement) | OAR | Class 1 | Orthopedic | No | 2014-11-24 |
| Device, Fixation, Proximal Femoral, Implant | JDO | Class 2 | Orthopedic | No | 2024-08-01 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2019-04-26 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented | MBF | Class 2 | Orthopedic | No | 2019-05-01 |
| Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | HSD | Class 2 | Orthopedic | No | 2019-05-01 |
| Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | KWT | Class 2 | Orthopedic | No | 2019-05-01 |
| Tap, Bone | HWX | Class 1 | Orthopedic | No | 2018-08-14 |
| Chisel, Surgical, Manual | FZO | Class 1 | General, Plastic Surgery | No | 2018-08-13 |
Proprietary Names
Synthes Cortical Screws
template
VOLT Locking and Cancellous Screws
VOLT Small Fragment Plating System
VOLT Mini Fragment Plating System
DePuy Synthes VOLT Mini Fragment Plating System
Bit, Drill
Manual Orthopedic Instruments
Instrument
surgical instrument
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
CHIA PERCPASSER, DePuy Mitek Instrument
HINDFOOT ARTHRODESIS NAIL
Saw Blade
Depuy Synthes MAXFRAME Multi-Axial Correction System
TROCHANTERIC FIXATION NAIL (TFN)
cutter
SYNTHES (USA) LOW-PROFILE WRIST FIXATOR
2.4mm Cannulated Screw
MANDIBLE EXTERNAL FIXATOR
DEPUY SYNTHES RETROGRDE FEMORAL NAIL ADVANCED SYSTEM
Depuy Synthes Retrograde Femoral Nail Advanced System and DePuy Synthes Locking Screws for Medullary Nails, 5 mm
DEPUY SYNTHES LOCKING SCREWS FOR MEDULLARY NAILS, 5 MM
Sterile 2.7mm recon Plates
HA COATED SCHANZ SCREWS
DePuy Synthes Trauma Orthopedic Plates And Screws
EIN End Cap
SYNTHES 4.5 MM VA-LCP CURVED CONDYLAR SYSTEM
REAMER (MULTIPLE BRANDS)
Trochanter Stabilization Plate DHS
DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm)
starter
extracter
SYNTHES EXTERNAL FIXATION DEVICES, MR CONDITIONAL
DHS-Troch Stabilizaiton Plate
Small Stature Ant. Cerv. Vertebral
Depth Gauge
DePuy Synthes MatrixSTERNUM Fixation System
Forceps
instrument
Cannulated Reduction Tool
Synthes 2.4MM VA-LCP INTERCARPAL FUSION SYSTEM
SYNTHES(USA) SYNTHES HYBRID EXTERNA
screw
guide
Guide, Surgical Instrument
Guide Block
Drill Sleeve
DePuy Synthes Cortex and Cannulated Screws
Case and Tray
tray
Bending Iron
Instrument, Bending Or Contouring
LCP CURVED PLATES
Zero-P VA
Synthes Zero-P VA
DePuy Synthes Retrograde Femoral Nail Advanced System
SYNTHES VA LCP ANKLE TRAUMA SYSTEM
Synthes (USA) VA-LCP 2-Col Narrow
SYNTHES DORSAL DISTAL RADIUS PLATE (DDRP) SYSTEM
HA Coated Schanz Screw
impactor
MODIFICATION TO SYNTHES CERVIFIX SYSTEM
SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEM
2.4mm VA LCP Two Column Volar DR
Synthes ClampFix System
ELASTIC INTRAMEDULLARY NAIL (EIN) E
DePuy Synthes Tibial Nail Advanced System DePuy Synthes Locking Screws for Medullary Nails, 4 and 5 mm
Appliance Fix, Nail Blade Plate Com
SYNTHES (USA) [SYNTHES} PERI-PROSTHETIC SCREWS
USS
SYNTHES (USA) RETROGRADE/ANTEGRADE FEMORAL NAIL SYSTEM
SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS
Expedium, Synapse
MODULAR FOOT SYSTEM - 2.7 MM MODULE
TITANIUM (TI) ALLOY HIGH TIBIAL OST
SOCKET PUSHER
Plate, fixation, bone
DePuy Synthes Maxillofacial Portfolio - MR Conditional
SYNTHES DISTRACTION OSTEOGENESIS SYSTEM, MR CONDITIONAL WITH EXPANDED INDICATIONS
Sternal Fixation System
Synthes Large Ex Fix, MR Cond.
SYNTHES (USA) LCP MODULAR FOOT PLATES
DePuy Synthes Trauma Screws
DePuy Synthes 2.7mm VA LCP Clavicle Plate System
Synthes 2.7mm LCP Ulna Osteotomy Plate System
DePuy Synthes Plates And Screws Portfolio
Screwdriver
SCREWDRIVER (MULTIPLE BRANDS)
SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM (MEDICAL AND POSTEROLATERAL DISTAL HUMERUS PLATES)
Plate fixation, bone
SYNTHES (USA) 2.4 MM LCP WRIST PLATE
chisel
General Surgical
MR Conditional
nail, fixation, bone
Synthes Neuro Plate and Screw Syste
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)