Jabil Inc. (Monument)

FDA Device Registration & Listing · Monument, CO, US · Registration 3015399803

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
3015399803
FEI Number
3015399803
Entity Name
Jabil Inc. (Monument)
City/State/Country
Monument, CO, US
Establishment Address
1051 Synthes Avenue, Monument, CO 80132, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Jabil Inc. (Owner Number: 9074019)
Owner / Operator Contact Address
10800 Roosevelt Blvd., Saint Petersburg, FL 33716, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered 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 Instrument 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

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-05-01
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-05-01
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2019-04-28
HWT Template Orthopedic Class 1 888.4800 2019-04-29
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2019-05-01
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-04-28
DZL Screw, Fixation, Intraosseous Dental Class 2 872.4880 2019-05-01
DZL Screw, Fixation, Intraosseous Dental Class 2 872.4880 2019-05-01
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2019-05-01
JEY Plate, Bone Dental Class 2 872.4760 2019-04-30
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-04-28
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-05-01
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2019-05-01
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2019-05-02
JEY Plate, Bone Dental Class 2 872.4760 2019-04-29
HRX Arthroscope Orthopedic Class 2 888.1100 2019-05-02
NDN Cement, Bone, Vertebroplasty Orthopedic Class 2 888.3027 2019-05-02
HTF Curette General, Plastic Surgery Class 1 878.4800 2019-04-26
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2019-05-01
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-04-30
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2019-05-01
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2019-04-29
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2019-04-29
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2019-05-01
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-05-01
JDQ Cerclage, Fixation Orthopedic Class 2 888.3010 2019-05-01
DZL Screw, Fixation, Intraosseous Dental Class 2 872.4880 2019-04-29
HTE Elevator General, Plastic Surgery Class 1 878.4800 2019-04-29
MQN External Mandibular Fixator And/Or Distractor Dental Class 2 872.4760 2019-04-29
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2024-05-02
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2024-05-02
HTW Bit, Drill Orthopedic Class 1 888.4540 2018-08-10
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-04-30
HWJ Awl Orthopedic Class 1 888.4540 2019-04-29
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2015-01-15
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2019-04-29
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2019-03-08
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-04-30
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-04-30
GEN Forceps, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2019-04-29
GFA Blade, Saw, General & Plastic Surgery, Surgical General, Plastic Surgery Class 1 878.4820 2018-08-10
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2019-05-02
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2019-05-02
JDQ Cerclage, Fixation Orthopedic Class 2 888.3010 2019-05-02
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-04-30
DZL Screw, Fixation, Intraosseous Dental Class 2 872.4880 2019-04-29
JEY Plate, Bone Dental Class 2 872.4760 2019-04-29
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2019-05-01
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2019-04-28
JEY Plate, Bone Dental Class 2 872.4760 2019-04-28
JEY Plate, Bone Dental Class 2 872.4760 2019-04-30
OCJ Spinal Channeling Instrument, Vertebroplasty Orthopedic Class 1 888.4540 2019-05-02
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-05-01
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2019-05-01
JDN Implant, Fixation Device, Spinal Orthopedic Class 2 888.3060 2019-04-29
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2019-04-29
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2019-03-08
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2019-03-08
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2019-04-29
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2019-04-29
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2019-04-29
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2019-04-29
JDW Pin, Fixation, Threaded Orthopedic Class 2 888.3040 2019-04-28
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2019-04-28
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2019-04-28
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-04-28
GXN Plate, Cranioplasty, Preformed, Non-Alterable Neurology Class 2 882.5330 2019-04-29
JDS Nail, Fixation, Bone Orthopedic Class 2 888.3030 2019-05-01
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2019-04-29
FZT Cutter, Surgical General, Plastic Surgery Class 1 878.4800 2019-04-29
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2019-05-01
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2019-05-01
NDN Cement, Bone, Vertebroplasty Orthopedic Class 2 888.3027 2019-05-02
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2019-04-30
JEY Plate, Bone Dental Class 2 872.4760 2019-05-01
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2019-05-02
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2019-04-29
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2019-03-08
DZL Screw, Fixation, Intraosseous Dental Class 2 872.4880 2019-05-01
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2019-04-30
HRX Arthroscope Orthopedic Class 2 888.1100 2019-05-02
NDN Cement, Bone, Vertebroplasty Orthopedic Class 2 888.3027 2019-05-02
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2019-04-29
JEY Plate, Bone Dental Class 2 872.4760 2019-04-29
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-05-01
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2019-05-01
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2019-05-01
JDW Pin, Fixation, Threaded Orthopedic Class 2 888.3040 2019-04-29
JEY Plate, Bone Dental Class 2 872.4760 2019-05-02
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2019-05-02
MQN External Mandibular Fixator And/Or Distractor Dental Class 2 872.4760 2019-04-29
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2020-09-25
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2020-09-25
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2019-04-30
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-05-01
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2019-05-02
JEY Plate, Bone Dental Class 2 872.4760 2019-04-30
DZL Screw, Fixation, Intraosseous Dental Class 2 872.4880 2019-05-01
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2019-04-29
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2019-04-29
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2019-04-29
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2019-04-29
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2019-04-29
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2019-04-29
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-04-28
KIH Dispenser, Cement Orthopedic Class 1 888.4200 2019-05-01
HTO Reamer Orthopedic Class 1 888.4540 2019-05-02
HRX Arthroscope Orthopedic Class 2 888.1100 2019-05-02
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2019-04-30
JEY Plate, Bone Dental Class 2 872.4760 2019-05-01
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2019-05-02
JEY Plate, Bone Dental Class 2 872.4760 2019-05-01
KTW Appliance, Fixation, Nail/Blade/Plate Combination, Single Component Orthopedic Class 2 888.3030 2024-08-01
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2024-08-01
LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite Orthopedic Class 2 888.3030 2024-08-01
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2024-08-01
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2024-08-01
HBG Drills, Burrs, Trephines & Accessories (Manual) Neurology Class 2 882.4300 2019-05-02
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2019-05-02
JEY Plate, Bone Dental Class 2 872.4760 2019-04-30
NKG Posterior Cervical Screw System Orthopedic Class 2 888.3075 2019-04-29
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2019-04-30
JDP Condylar Plate Fixation Implant Orthopedic Class 2 888.3030 2019-04-30
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-04-30
GEY Motor, Surgical Instrument, Ac-Powered General, Plastic Surgery Class 1 878.4820 2019-05-01
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2019-05-01
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2019-05-01
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2019-05-02
HTO Reamer Orthopedic Class 1 888.4540 2019-03-08
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2019-04-29
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2019-05-01
HXW Bender Orthopedic Class 1 888.4540 2019-04-29
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-05-01
JEY Plate, Bone Dental Class 2 872.4760 2020-10-22
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2019-05-01
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2019-05-02
HWD Starter, Bone Screw Orthopedic Class 1 888.4540 2019-05-01
JDQ Cerclage, Fixation Orthopedic Class 2 888.3010 2019-05-01
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2019-05-01
KWI Prosthesis, Elbow, Hemi-, Radial, Polymer Orthopedic Class 2 888.3170 2019-05-02
HWB Extractor Orthopedic Class 1 888.4540 2019-03-08
JEY Plate, Bone Dental Class 2 872.4760 2019-04-29
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-04-29
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2019-04-29
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2019-04-29
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2019-04-29
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2019-04-29
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2019-04-29
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2019-04-29
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2019-03-08
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2019-03-08
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2019-04-30
MJG Device, Percutaneous, Biopsy General, Plastic Surgery Class 1 878.4800 2019-05-02
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-04-30
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2019-04-30
LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite Orthopedic Class 2 888.3030 2019-05-01
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2019-04-29
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-05-01
HTJ Gauge, Depth Orthopedic Class 1 888.4300 2019-04-29
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2024-05-29
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2024-05-29
HXB Probe Orthopedic Class 1 888.4540 2019-04-29
HTD Forceps General, Plastic Surgery Class 1 878.4800 2019-04-29
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2019-05-02
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-05-02
LOD Bone Cement Orthopedic Class 2 888.3027 2019-05-02
NDN Cement, Bone, Vertebroplasty Orthopedic Class 2 888.3027 2019-05-02
LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite Orthopedic Class 2 888.3030 2019-04-29
KTW Appliance, Fixation, Nail/Blade/Plate Combination, Single Component Orthopedic Class 2 888.3030 2019-04-30
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2019-05-01
JDS Nail, Fixation, Bone Orthopedic Class 2 888.3030 2019-05-01
JEY Plate, Bone Dental Class 2 872.4760 2019-04-29
FZX Guide, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2019-03-08
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2019-05-02
OJV Single Use Instrument Tray General, Plastic Surgery Class 1 878.4800 2019-05-02
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2019-05-01
OAT Implant, Endosseous, Orthodontic Dental Class 2 872.3640 2019-04-30
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2019-05-02
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2019-04-29
DZL Screw, Fixation, Intraosseous Dental Class 2 872.4880 2019-05-01
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-05-01
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2019-04-30
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-04-30
HBW Fastener, Plate, Cranioplasty Neurology Class 2 882.5360 2019-04-28
HXP Instrument, Bending Or Contouring Orthopedic Class 1 888.4540 2019-04-29
JDW Pin, Fixation, Threaded Orthopedic Class 2 888.3040 2019-05-01
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2019-04-30
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2019-05-01
JDS Nail, Fixation, Bone Orthopedic Class 2 888.3030 2019-03-08
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2019-04-29
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2019-05-02
JEY Plate, Bone Dental Class 2 872.4760 2019-04-30
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2019-04-29
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2026-02-18
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2026-02-18
JEY Plate, Bone Dental Class 2 872.4760 2019-04-29
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-04-30
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2019-04-30
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-04-30
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2019-04-30
HWN Instrument, Compression Orthopedic Class 1 888.4540 2019-05-02
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-05-01
MOQ Battery, Replacement, Rechargeable General, Plastic Surgery Class 1 878.4820 2019-05-01
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2019-05-01
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2019-04-29
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2019-04-29
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2019-04-29
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2019-04-29
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2019-04-29
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2019-04-30
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-04-30
JDQ Cerclage, Fixation Orthopedic Class 2 888.3010 2019-04-30
JDS Nail, Fixation, Bone Orthopedic Class 2 888.3030 2019-04-29
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2019-05-01
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-05-01
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-05-01
MQN External Mandibular Fixator And/Or Distractor Dental Class 2 872.4760 2019-05-01
HRX Arthroscope Orthopedic Class 2 888.1100 2019-05-01
HTO Reamer Orthopedic Class 1 888.4540 2019-05-01
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2019-05-01
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-05-01
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-04-30
JDS Nail, Fixation, Bone Orthopedic Class 2 888.3030 2019-04-28
GAQ Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile General, Plastic Surgery Class 2 878.4495 2019-04-29
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2019-04-29
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2019-04-28
HWA Impactor Orthopedic Class 1 888.4540 2019-04-29
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2019-05-01
DZL Screw, Fixation, Intraosseous Dental Class 2 872.4880 2019-05-01
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2019-04-29
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2019-04-29
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-04-30
HXD Clamp General, Plastic Surgery Class 1 878.4800 2019-04-28
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2019-05-02
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2019-04-30
ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece Ear, Nose, Throat Class 2 874.4250 2019-04-29
DZI Drill, Bone, Powered Dental Class 2 872.4120 2019-04-29
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2019-04-29
HBE Drills, Burrs, Trephines & Accessories (Simple, Powered) Neurology Class 2 882.4310 2019-04-29
HST Apparatus, Traction, Non-Powered Orthopedic Class 1 888.5850 2019-04-29
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-05-01
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-05-02
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2019-05-02
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2019-05-02
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2019-05-02
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2019-05-02
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2019-05-02
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2019-05-02
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2019-04-29
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2019-05-01
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2019-05-01
HXG Tamp Orthopedic Class 1 888.4540 2019-04-29
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-05-02
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2019-03-08
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2019-03-08
JEY Plate, Bone Dental Class 2 872.4760 2019-04-30
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2019-05-01
HTC Pliers, Surgical General, Plastic Surgery Class 1 878.4800 2019-04-29
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2019-04-30
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-04-30
MQN External Mandibular Fixator And/Or Distractor Dental Class 2 872.4760 2019-05-01
GEA Cannula, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2019-03-04
JEY Plate, Bone Dental Class 2 872.4760 2019-05-01
KTW Appliance, Fixation, Nail/Blade/Plate Combination, Single Component Orthopedic Class 2 888.3030 2019-05-01
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2019-05-01
GFF Bur, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4820 2019-05-01
HSZ Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2019-05-01
GFA Blade, Saw, General & Plastic Surgery, Surgical General, Plastic Surgery Class 1 878.4820 2019-05-01
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2020-11-03
JDS Nail, Fixation, Bone Orthopedic Class 2 888.3030 2020-11-03
LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite Orthopedic Class 2 888.3030 2019-04-30
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2019-05-01
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2019-04-30
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-04-30
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2019-04-29
LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite Orthopedic Class 2 888.3030 2019-04-29
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2019-04-29
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2019-04-29
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2019-04-29
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2019-04-29
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2019-04-29
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2019-03-08
JDS Nail, Fixation, Bone Orthopedic Class 2 888.3030 2019-05-02
HXC Wrench Orthopedic Class 1 888.4540 2019-04-29
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2019-04-29
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-05-01
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2019-05-01
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2019-04-29
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2019-04-29
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2019-04-29
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2019-04-29
NQW Orthosis, Spine, Plate, Laminoplasty, Metal Orthopedic Class 2 888.3050 2019-04-30
GAD Retractor General, Plastic Surgery Class 1 878.4800 2018-08-10
GXR Cover, Burr Hole Neurology Class 2 882.5250 2019-05-02
GWO Plate, Cranioplasty, Preformed, Alterable Neurology Class 2 882.5320 2019-05-02
GXR Cover, Burr Hole Neurology Class 2 882.5250 2019-04-30
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-04-30
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2019-04-29
GFG Bit, Surgical General, Plastic Surgery Class 1 878.4820 2019-04-29
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2019-04-29
KTW Appliance, Fixation, Nail/Blade/Plate Combination, Single Component Orthopedic Class 2 888.3030 2019-04-30
JEY Plate, Bone Dental Class 2 872.4760 2019-05-02
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2019-05-01
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2019-05-01
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2019-04-29
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2019-04-29
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2019-04-29
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-05-01

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Jabil 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
3015410662 Jabil Inc. (Wilson Drive) W Chester, PA, US
3011246727 Jabil Circuit Sdn. Bhd. Bayan Lepas Pulau Pinang, MY
3003512059 NYPRO DR, LLC (Bldg 11) Haina San Cristobal, DO
3004730544 NYPRO DR, LLC (Building 52) Haina San Cristobal, DO
1424235 Nypro Inc. (Chicago) GURNEE, IL, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K042598 Zimmer, Inc. PERIARTICULAR LOCKING PLATES AND SCREWS, 2357 AND 2359 SERIES 2004-10-29
K190842 Jiangsu Trauhui Medical Instrument Co., Ltd. Comus Locking Plate systems 2020-02-03
K130510 Arthrex, Inc. ARTHREX COMPRESSION PLATES 2013-09-25
K202803 Newclip Technics Activmotion S DTO 2021-12-16
K062348 Medtronic Neurosurgery TIMESH SELF DRILLING SCREW 2006-09-08

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0034-2022 Flower Orthopedics Corporation 2
Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
Z-0014-2014 Synthes USA HQ, Inc. 2
Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
Z-0026-2013 Orthohelix Surgical Designs Inc 2
OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0026-2016 Ortho Solutions Inc 330 Franklin Tnpk 2
Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw
Z-0027-2013 Orthohelix Surgical Designs Inc 2
OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.

Similar Registrations

Registration Number Establishment Name Location
3013843055 BEIJING AK MEDICAL CO, LTD Changping District Beijing, CN
3022777867 FIXIER S.A. DE C.V. Doctor Mora Guanajuato, MX
3017209758 NEBULA SURGICAL PRIVATE LIMITED Rajkot Gujarat, IN
3017609305 PRIMEMED INC. Sungnam-city Gyeonggi, KR
3015410662 Jabil Inc. (Wilson Drive) W Chester, PA, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015399803. Last updated year: 2026. Please use registration number 3015399803 when referencing this establishment in official correspondence.
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