Jabil Inc. (Brandywine)

FDA Device Registration & Listing · W Chester, PA, US · Registration 3015212339

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
3015212339
FEI Number
3015212339
Entity Name
Jabil Inc. (Brandywine)
City/State/Country
W Chester, PA, US
Establishment Address
1303 Goshen Parkway, W Chester, PA 19380, 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

CMFD Mandible Forceps instrument Cannulated Reduction Tool Stryker F1 Charger Module HANDLE, SCALPEL Handle SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEM SYNTHES USS, CLICK`X, USS VAS, DUAL-OPENING USS AND SMALL STATURE USS stylet hammer Craniomaxillofacial Distraction System (CMFD) Synthes Neuro Plate and Screw Syste instrument, cutting, orthopedic extracter instrument Bit, Drill Depth Gauge Zero-P VA Synthes Zero-P VA DePuy Synthes Retrograde Femoral Nail Advanced System Manual Orthopedic Instruments Instrument surgical instrument ORTHOPEDIC MANUAL SURGICAL INSTRUMENT CHIA PERCPASSER, DePuy Mitek Instrument Bending Iron Instrument, Bending Or Contouring tape GENERAL AND PLASTIC SURGERY Small Stature Ant. Cerv. Vertebral Screwdriver SCREWDRIVER (MULTIPLE BRANDS) SYNTHES TITANIUM MULTI-VECTOR DISTRACTOR MODIFICATION TO SYNTHES CERVIFIX SYSTEM REAMER (MULTIPLE BRANDS) TROCHANTERIC FIXATION NAIL (TFN) SYNTHES USS (10MM SIDE OPENING SCREWS SYNTHES DISTRACTION OSTEOGENESIS SYSTEM, MR CONDITIONAL WITH EXPANDED INDICATIONS DePuy Synthes MatrixSTERNUM Fixation System Torque Limiting Attachment chisel impactor SYNTHES(USA) SYNTHES HYBRID EXTERNA SYNTHES UNIVERSAL SPINAL SYSTEM USS template SYNTHES EXTERNAL FIXATION DEVICES, MR CONDITIONAL MODIFICATION TO THE SYNTHES (USA) UNIVERSAL SPINAL HOOK Case and Tray tray Synthes Dual-Opening USS cutter

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MQN External Mandibular Fixator And/Or Distractor Dental Class 2 872.4760 2023-06-23
MQN External Mandibular Fixator And/Or Distractor Dental Class 2 872.4760 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
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
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
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
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2019-04-29
HXQ Crimper, Pin Orthopedic Class 1 888.4540 2019-04-29
HTD Forceps General, Plastic Surgery Class 1 878.4800 2019-04-29
HXD Clamp General, Plastic Surgery Class 1 878.4800 2019-04-28
HXW Bender Orthopedic Class 1 888.4540 2019-04-29
JEY Plate, Bone Dental Class 2 872.4760 2019-04-29
LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite Orthopedic Class 2 888.3030 2019-04-29
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2018-08-26
LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite Orthopedic Class 2 888.3030 2019-04-29
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 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
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2019-04-29
GDZ Handle, Scalpel General, Plastic Surgery Class 1 878.4800 2018-08-26
HXG Tamp Orthopedic Class 1 888.4540 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
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
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
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
GAH Stylet, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2019-04-29
FZY Hammer, Surgical General, Plastic Surgery Class 1 878.4800 2019-09-20
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2019-04-29
MQN External Mandibular Fixator And/Or Distractor Dental Class 2 872.4760 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
GWO Plate, Cranioplasty, Preformed, Alterable Neurology Class 2 882.5320 2019-04-29
PBJ Cranial Distraction System Neurology Class 2 882.5330 2023-06-23
DZL Screw, Fixation, Intraosseous Dental Class 2 872.4880 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
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2019-04-29
JEY Plate, Bone Dental Class 2 872.4760 2019-04-29
JEY Plate, Bone Dental Class 2 872.4760 2019-04-29
JEY Plate, Bone Dental Class 2 872.4760 2019-04-29
MJO Prosthesis, Intervertebral Disc Unknown Class 3 N/A 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 2019-04-29
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2019-04-29
MDI Prosthesis, Rib Replacement Orthopedic Class 2 888.3070 2019-04-29
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2019-04-29
HTZ Instrument, Cutting, Orthopedic General, Plastic Surgery Class 1 878.4800 2019-04-29
HWB Extractor Orthopedic Class 1 888.4540 2019-03-08
HWN Instrument, Compression Orthopedic Class 1 888.4540 2019-04-29
GEA Cannula, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2019-03-04
HTW Bit, Drill Orthopedic Class 1 888.4540 2018-08-10
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
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
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2019-04-29
DZJ Driver, Wire, And Bone Drill, Manual Dental Class 2 872.4120 2019-04-29
HTJ Gauge, Depth Orthopedic Class 1 888.4300 2019-04-29
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2019-04-29
MQN External Mandibular Fixator And/Or Distractor Dental Class 2 872.4760 2019-04-29
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-04-29
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 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
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 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
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
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
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
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2019-04-29
HTC Pliers, Surgical General, Plastic Surgery Class 1 878.4800 2019-04-29
GEN Forceps, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 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
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2015-01-15
HWM Osteotome General, Plastic Surgery Class 1 878.4800 2019-04-29
HXP Instrument, Bending Or Contouring Orthopedic Class 1 888.4540 2019-04-29
FTY Tape, Measuring, Rulers And Calipers General, Plastic Surgery Class 1 878.4800 2019-04-29
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2019-04-29
HXX Screwdriver Orthopedic Class 1 888.4540 2019-04-26
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
GAD Retractor General, Plastic Surgery Class 1 878.4800 2018-08-10
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
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
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 2019-04-29
DZL Screw, Fixation, Intraosseous Dental Class 2 872.4880 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
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
JDW Pin, Fixation, Threaded Orthopedic Class 2 888.3040 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 2019-04-29
HXC Wrench Orthopedic Class 1 888.4540 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 2019-04-29
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
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 2019-04-29
HTO Reamer Orthopedic Class 1 888.4540 2019-03-08
HXB Probe Orthopedic Class 1 888.4540 2019-04-29
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2019-04-29
HTR Rasp General, Plastic Surgery Class 1 878.4800 2019-04-29
JEY Plate, Bone Dental Class 2 872.4760 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 2019-04-29
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 2019-04-29
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2019-04-29
GDG Hook, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2019-04-29
GXN Plate, Cranioplasty, Preformed, Non-Alterable Neurology Class 2 882.5330 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
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
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2019-04-29
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 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
JDS Nail, Fixation, Bone Orthopedic Class 2 888.3030 2019-04-29
JDW Pin, Fixation, Threaded Orthopedic Class 2 888.3040 2019-04-29
EZX Mesh, Surgical, Metal General, Plastic Surgery Class 2 878.3300 2019-04-29
GAQ Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile General, Plastic Surgery Class 2 878.4495 2019-04-29
GFC Driver, Surgical, Pin General, Plastic Surgery Class 1 878.4820 2023-06-23
FZO Chisel, Surgical, Manual General, Plastic Surgery Class 1 878.4800 2018-08-13
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2019-04-29
HWA Impactor Orthopedic Class 1 888.4540 2019-04-29
JDS Nail, Fixation, Bone Orthopedic Class 2 888.3030 2019-04-29
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 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 2019-04-29
JEY Plate, Bone Dental Class 2 872.4760 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
GXN Plate, Cranioplasty, Preformed, Non-Alterable Neurology Class 2 882.5330 2019-04-29
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 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
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2019-04-29
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2019-04-29
HWT Template Orthopedic Class 1 888.4800 2019-04-29
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2019-04-29
JDW Pin, Fixation, Threaded Orthopedic Class 2 888.3040 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
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
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 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
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
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
KTZ Caliper Orthopedic Class 1 888.4150 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 2019-04-29
HWR Driver, Prosthesis Orthopedic Class 1 888.4540 2019-04-29
MJO Prosthesis, Intervertebral Disc Unknown Class 3 N/A 2019-04-29
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2019-04-29
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 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
FZT Cutter, Surgical General, Plastic Surgery Class 1 878.4800 2019-04-29

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
K032604 Co-Ligne AG GII SPINAL FIXATION SYSTEM 2004-01-20
K964304 Osteonics Corp. OSTEONICS SPINAL SYSTEM-TOPLOADING TRANSVERSE CONNECTOR ASSEMBLY 1997-01-17
K963639 Acromed Corp. ACROMED PEDICLE SCREW 1996-11-14
K012175 Encore Orthopedics, Inc. PASS SPINAL SYSTEM 2001-07-31
K032752 R&B Surgical Solutions, LLC R&B SURGICAL SMARTPLATE CERVICAL PLATE SYSTEM 2003-12-03

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0026-2011 Zimmer Inc. 2
SpeedLink 5.5 Transverse Connector Short 39.5-44mm, non-sterile, 1302-55S
Z-0027-2011 Zimmer Inc. 2
SpeedLink 5.5 Transverse Connector Medium 43-51mm, non-sterile, 1302-55M
Z-0028-2011 Zimmer Inc. 2
SpeedLink 5.5 Transverse Connector Long 50-65mm, non-sterile, 1302-55L
Z-0029-2011 Zimmer Inc. 2
SpeedLink 5.5 Transverse Connector X-Long 60-75mm, non-sterile, 1302-55XL
Z-0030-2011 Zimmer Inc. 2
SpeedLink 6.0 Transverse Connector Short 39.5-44mm, non-sterile, 1304-60S

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015212339. Last updated year: 2026. Please use registration number 3015212339 when referencing this establishment in official correspondence.
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