Jabil Inc. (Elmira)

FDA Device Registration & Listing · Horseheads, NY, US · Registration 3015440604

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
3015440604
FEI Number
3015440604
Entity Name
Jabil Inc. (Elmira)
City/State/Country
Horseheads, NY, US
Establishment Address
35 Airport Road, Horseheads, NY 14845, 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

Staple Manual Orthopedic Instruments Instrument surgical instrument ORTHOPEDIC MANUAL SURGICAL INSTRUMENT CHIA PERCPASSER, DePuy Mitek Instrument Synthes Dual-Opening USS MODULAR FOOT SYSTEM - 2.7 MM MODULE REAMER (MULTIPLE BRANDS) VOLT™ Ankle Trauma 2.7/3.5 Plating System; VOLT™ Calcaneus 2.7 Plating System SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM (MEDICAL AND POSTEROLATERAL DISTAL HUMERUS PLATES) MANDIBLE EXTERNAL FIXATOR LCP Bit, Drill SYNTHES (USA) LCP MODULAR FOOT PLATES SYNTHES (USA) EXTERNAL MULTI VECTOR MANDIBLE DISTRACTOR SYNTHES (USA) RETROGRADE/ANTEGRADE FEMORAL NAIL SYSTEM MR Conditional DePuy Synthes Plates And Screws Portfolio Depuy Synthes MAXFRAME Multi-Axial Correction System SYNTHES (USA) 2.4 MM LCP WRIST PLATE Staple LCP CURVED PLATES MODIFICATION TO THE SYNTHES (USA) UNIVERSAL SPINAL HOOK HA COATED SCHANZ SCREWS instrument DePuy Synthes Maxillofacial Portfolio - MR Conditional Stryker F1 Charger Module Synthes Neuro Plate and Screw Syste SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEM SYNTHES (USA) LOW-PROFILE WRIST FIXATOR Appliance Fix, Nail Blade Plate Com SS Elastic IM Nail TROCHANTERIC FIXATION NAIL (TFN) USS Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment DePuy Synthes Maxillofacial Portfolio - MR Conditional VOLT Locking and Cancellous Screws VOLT Small Fragment Plating System VOLT Mini Fragment Plating System DePuy Synthes VOLT Mini Fragment Plating System 4.5 MM AND 6.5 MM HEADLESS COMPRESS guide Guide, Surgical Instrument Guide Block Drill Sleeve SYNTHES (USA) [SYNTHES] MINI EXTERNAL FIXATOR SYNTHES(USA) SYNTHES HYBRID EXTERNA SYNTHES UNIVERSAL SPINAL SYSTEM Synthes2.4 LCP Vol. Col. Dist. Radi MANDIBLE EXTERNAL FIXATOR template Ankle Trauma System General Surgical

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2019-04-30
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-04-30
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2022-03-31
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-04-30
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
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
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
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2015-01-15
EZX Mesh, Surgical, Metal General, Plastic Surgery Class 2 878.3300 2019-04-29
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 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
JEY Plate, Bone Dental Class 2 872.4760 2019-04-30
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2019-04-30
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2019-04-30
KTW Appliance, Fixation, Nail/Blade/Plate Combination, Single Component Orthopedic Class 2 888.3030 2019-04-30
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-04-30
HTO Reamer Orthopedic Class 1 888.4540 2019-03-08
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2019-04-30
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-04-30
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-04-30
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-04-30
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
LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite Orthopedic Class 2 888.3030 2019-04-30
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
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2019-04-29
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2019-04-29
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2026-06-09
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
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 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
JEY Plate, Bone Dental Class 2 872.4760 2019-04-30
JEY Plate, Bone Dental Class 2 872.4760 2019-04-29
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-04-30
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2019-04-29
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 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
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2019-04-29
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-04-30
MQN External Mandibular Fixator And/Or Distractor Dental Class 2 872.4760 2019-04-29
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-04-30
JDO Device, Fixation, Proximal Femoral, Implant Orthopedic Class 2 888.3030 2019-04-30
JEY Plate, Bone Dental Class 2 872.4760 2019-04-30
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-04-30
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-04-30
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-04-30
JEY Plate, Bone Dental Class 2 872.4760 2019-04-30
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
HTW Bit, Drill Orthopedic Class 1 888.4540 2018-08-10
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 2019-04-28
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2019-04-29
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2019-04-29
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-04-30
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
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2019-04-29
DZJ Driver, Wire, And Bone Drill, Manual Dental Class 2 872.4120 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
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2019-04-29
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-04-30
LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite Orthopedic Class 2 888.3030 2019-04-30
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2019-04-30
JDO Device, Fixation, Proximal Femoral, Implant Orthopedic Class 2 888.3030 2019-04-30
JEY Plate, Bone Dental Class 2 872.4760 2019-04-30
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-04-30
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-04-30
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 2019-04-30
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-04-30
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2019-04-30
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-04-30
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2019-04-30
JDQ Cerclage, Fixation Orthopedic Class 2 888.3010 2019-04-30
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-04-30
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-04-28
DZL Screw, Fixation, Intraosseous Dental Class 2 872.4880 2019-04-30
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2019-03-08
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2024-08-01
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2024-08-01
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2024-08-01
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2024-08-01
JDS Nail, Fixation, Bone Orthopedic Class 2 888.3030 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
KTW Appliance, Fixation, Nail/Blade/Plate Combination, Single Component Orthopedic Class 2 888.3030 2024-08-01
JDO Device, Fixation, Proximal Femoral, Implant Orthopedic Class 2 888.3030 2024-08-01
KTW Appliance, Fixation, Nail/Blade/Plate Combination, Single Component 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
JDP Condylar Plate Fixation Implant Orthopedic Class 2 888.3030 2024-08-01
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2024-08-01
LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite Orthopedic Class 2 888.3030 2024-08-01
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2019-04-28
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-04-30
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-04-30
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2022-03-31
KTW Appliance, Fixation, Nail/Blade/Plate Combination, Single Component Orthopedic Class 2 888.3030 2019-04-30
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
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2019-04-30
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2019-04-29
JEY Plate, Bone Dental Class 2 872.4760 2019-04-30
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2019-04-30
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
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2019-04-29
JDQ Cerclage, Fixation Orthopedic Class 2 888.3010 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
KTW Appliance, Fixation, Nail/Blade/Plate Combination, Single Component Orthopedic Class 2 888.3030 2019-04-30
HWN Instrument, Compression Orthopedic Class 1 888.4540 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
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 2019-04-30
JEY Plate, Bone Dental Class 2 872.4760 2019-04-30
JEY Plate, Bone Dental Class 2 872.4760 2024-08-01
DZL Screw, Fixation, Intraosseous Dental Class 2 872.4880 2019-04-30
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2019-04-30
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2018-08-26
JEY Plate, Bone Dental Class 2 872.4760 2019-04-29
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
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2019-04-29
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2019-04-30
LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite Orthopedic Class 2 888.3030 2019-04-30
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 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
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
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2019-04-30
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2019-04-30
JDS Nail, 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
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2019-04-30
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
JEY Plate, Bone Dental Class 2 872.4760 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
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
JEY Plate, Bone Dental Class 2 872.4760 2019-04-30
HSZ Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2019-04-30
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-04-30
JDS Nail, Fixation, Bone Orthopedic Class 2 888.3030 2019-04-29
JDW Pin, Fixation, Threaded Orthopedic Class 2 888.3040 2019-04-29
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2019-04-29
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2019-04-29
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-04-30
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2019-04-29
NEI Prosthesis, Condyle, Mandibular, Temporary Dental Class 2 872.4770 2024-08-01
MQN External Mandibular Fixator And/Or Distractor Dental Class 2 872.4760 2024-08-01
DZL Screw, Fixation, Intraosseous Dental Class 2 872.4880 2024-08-01
DZK Wire, Fixation, Intraosseous Dental Class 2 872.4880 2024-08-01
OAT Implant, Endosseous, Orthodontic Dental Class 2 872.3640 2024-08-01
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
NQW Orthosis, Spine, Plate, Laminoplasty, Metal Orthopedic Class 2 888.3050 2019-04-30
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2019-04-30
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2024-05-02
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2024-05-02
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2019-04-29
JDW Pin, Fixation, Threaded Orthopedic Class 2 888.3040 2019-04-29
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-04-29
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2019-04-29
JEY Plate, Bone Dental Class 2 872.4760 2019-04-30
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2019-04-30
FZX Guide, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2019-03-08
HWX Tap, Bone Orthopedic Class 1 888.4540 2018-08-14
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 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
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
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 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
JDQ Cerclage, Fixation Orthopedic Class 2 888.3010 2019-04-30
OAT Implant, Endosseous, Orthodontic Dental Class 2 872.3640 2019-04-30
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
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2019-04-29
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2019-04-29
GXR Cover, Burr Hole Neurology Class 2 882.5250 2019-04-30
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-04-30
JEY Plate, Bone Dental Class 2 872.4760 2019-04-30
LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite Orthopedic Class 2 888.3030 2019-04-29
JDW Pin, Fixation, Threaded Orthopedic Class 2 888.3040 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
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
NKB Thoracolumbosacral Pedicle Screw System 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
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
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
OAT Implant, Endosseous, Orthodontic Dental Class 2 872.3640 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 2019-04-30
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
JEY Plate, Bone Dental Class 2 872.4760 2019-04-29
NKG Posterior Cervical Screw System Orthopedic Class 2 888.3075 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
MQN External Mandibular Fixator And/Or Distractor Dental Class 2 872.4760 2019-04-29
HWT Template Orthopedic Class 1 888.4800 2019-04-29
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 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
GFF Bur, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4820 2018-08-10

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
K062348 Medtronic Neurosurgery TIMESH SELF DRILLING SCREW 2006-09-08
K063244 Arc Surgical, LLC ARC SURGICAL BONE REDUCTION SCREW 2006-12-27
K972722 Orthopedic Designs, Inc. ULTIMATE COMPRESSION SCREW SYSTEM 1998-01-23
K192974 Tyber Medical, LLC Tyber Medical Trauma Screw 2020-01-08
K082949 OrthoPediatrics Corp. ORTHOPEDIATRICS BONE SCREWS 2008-11-25

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
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.
Z-0043-2018 MicroPort Orthopedics Inc. 2
MicroPort Orthopedics SCHANZ SCREW SELF DRILL, SIZE 4mm, REF 20070057, STERILE R Product Usage: MPO Total Hip Systems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015440604. Last updated year: 2026. Please use registration number 3015440604 when referencing this establishment in official correspondence.
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