Jabil Switzerland Manufacturing GmbH (Le Locle)

FDA Device Registration & Listing · Le Locle Neuchatel, CH · Registration 3015831087

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
3015831087
FEI Number
3015831087
Entity Name
Jabil Switzerland Manufacturing GmbH (Le Locle)
City/State/Country
Le Locle Neuchatel, CH
Establishment Address
Chemin Blanc 36 - 38, Le Locle Neuchatel CH-2400, CH
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

Bengal, Leopard VIPER Prime, VIPER PRIME Fenestrated, EXPEDIUM Verse Fenestrated Symphony OCT System OCT Spinal Fixation System, SYMPHONY OCT System Instrument EXPEDIUM VERSE SPINE SYSTEM EXPEDIUM SPINE SYSTEM Expedium SKYLINE Symphony OCT System Viper Mixer EXPEDIUM Spine System Viper System EXPEDIUM Spine System X-MESH EXPANDABLE CAGE SYSTEM EXPEDIUM Spine System Moss Miami Expedium, Viper, Viper 2 Moss Miami Viper System Monarch Spine System Viper Prime TriALTIS COUGAR LATERAL CAGE SYSTEM EXPEDIUM VERSE SPINE SYSTEM Expedium, Viper, Viper 2 Needle DePuy Pulse Lumbar Cage System Forceps instrument Cannulated Reduction Tool UNIPLATE ACP System COUGAR LATERAL CAGE SYSTEM Viper 2 CONCORDE BULLET SPINAL SYSTEM Moss Miami CONCORDE BULLET SPINAL SYSTEM guide Guide, Surgical Instrument Guide Block Drill Sleeve Expedium, Viper, Universal Navigation Instruments TriALTIS Spine System Confidence High Viscosity Cement Expedium, Expedium Anterior Screwdriver SCREWDRIVER (MULTIPLE BRANDS) EXPEDIUM Spine System Bengal, Concorde Bullet, Concorde, Cougar, Devex, Leopard Bengal, Bengal Stackable, Concorde Bullet, Concorde Inline, Cougar, Cougar LS Lateral EAGLE PLUS MICRO ACP SYSTEM EXPEDIUM Spine System Surgical Titanium Mesh Moss Miami EXPEDIUM Spine System Cougar LS Lateral Cage System SKYLINE Anterior Cervical Plate System Expedium, Moss Miami Expedium, Viper Cougar LS Moss Miami Mountaineer OCT Spinal System, Summit Manual Orthopedic Instruments Instrument surgical instrument ORTHOPEDIC MANUAL SURGICAL INSTRUMENT CHIA PERCPASSER, DePuy Mitek Instrument Devex Mesh System SUMMIT SI OCT Spinal Fixation System SKYLINE Anterior Cervical Plate System Viper F2 Facet Fixation System Viper Prime EXPEDIUM Spine System Expedium, Synapse SLIM-LOC Mountaineer OCT Spinal System, Summit Viper Mountaineer OCT Accessories Arthroscopic Instruments, Suture Graspers EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra Rods Expedium, Viper template Moss Miami Spine System Stryker F1 Charger Module CONFIDENCE High Viscosity Spinal Cement, Expedium Fenestrated Screw Systems, VIPER Fenestrated Screw Systems Expedium, Viper, Viper 2 VOLT Locking and Cancellous Screws VOLT Small Fragment Plating System VOLT Mini Fragment Plating System DePuy Synthes VOLT Mini Fragment Plating System CONCORDE BULLET SPINAL SYSTEM VIPER Prime, VIPER PRIME Fenestrated, EXPEDIUM Verse Fenestrated Symphony OCT System Needle Concorde Bullet TriALTIS Monarch Spine System Uniplate Viper Prime

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2019-09-23
NKG Posterior Cervical Screw System Orthopedic Class 2 888.3075 2019-09-23
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2019-09-23
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-09-23
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2019-09-23
NKG Posterior Cervical Screw System Orthopedic Class 2 888.3075 2019-09-23
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2019-09-23
MJG Device, Percutaneous, Biopsy General, Plastic Surgery Class 1 878.4800 2019-05-02
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2021-02-26
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2021-02-26
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2021-02-26
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2019-09-23
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2019-09-23
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2019-09-23
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2019-09-23
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2019-09-23
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2019-09-23
NKG Posterior Cervical Screw System Orthopedic Class 2 888.3075 2021-01-20
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2019-09-23
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2019-09-23
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2019-09-23
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2019-09-23
JDZ Mixer, Cement, For Clinical Use Orthopedic Class 1 888.4210 2019-06-14
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2019-09-23
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2019-09-23
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2019-09-23
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2019-09-23
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2019-09-23
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2019-09-23
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2019-09-23
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2019-09-23
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2019-09-23
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2019-09-23
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2019-09-23
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2019-09-23
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2019-09-23
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2019-09-23
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2019-09-23
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2019-09-23
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2019-09-23
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2019-09-23
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2019-09-23
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2019-09-23
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2019-09-23
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2019-09-23
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2019-09-23
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2019-09-23
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2019-09-23
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2019-09-23
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2019-09-23
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2019-09-23
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2019-09-23
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2019-09-23
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2019-09-23
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2019-09-23
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2019-09-23
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2019-09-23
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2019-09-23
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2019-09-23
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2019-09-23
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2019-09-23
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2019-09-23
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-05-01
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2023-12-01
HXW Bender Orthopedic Class 1 888.4540 2019-04-29
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2019-09-23
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2019-09-23
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2019-09-23
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2019-09-23
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2019-09-23
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2019-09-23
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2019-09-23
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2019-09-23
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2019-09-23
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2019-09-23
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2019-09-23
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2019-09-23
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2019-09-23
GAB Needle, Suturing, Disposable General, Plastic Surgery Class 1 878.4800 2019-09-23
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2019-09-23
HTD Forceps General, Plastic Surgery Class 1 878.4800 2019-04-29
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2019-09-23
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2019-09-23
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2019-09-23
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2019-09-23
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2019-09-23
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2019-09-23
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2019-09-23
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2019-09-23
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2019-09-23
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2019-09-23
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2019-09-23
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2019-09-23
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2019-09-23
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2019-09-23
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2019-09-23
FZX Guide, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2019-03-08
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2019-09-23
PML Bone Cement, Posterior Screw Augmentation Orthopedic Class 2 888.3027 2024-09-24
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2024-09-24
NDN Cement, Bone, Vertebroplasty Orthopedic Class 2 888.3027 2019-09-23
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2019-09-23
HXX Screwdriver Orthopedic Class 1 888.4540 2019-04-26
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2019-09-23
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2019-09-23
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2019-09-23
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2019-09-23
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2019-09-23
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2019-09-23
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2019-09-23
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2019-09-23
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2019-09-23
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2019-09-23
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2019-09-23
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2019-09-23
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2019-09-23
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2019-09-23
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2019-09-23
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2019-09-23
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2019-09-23
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2019-09-23
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2019-09-23
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2019-09-23
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2019-09-23
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2019-09-23
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2019-09-23
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2019-09-23
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2019-09-23
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2019-09-23
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2019-09-23
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2019-09-23
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2019-09-23
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2019-09-23
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2019-09-23
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2019-09-23
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2019-09-23
HWJ Awl Orthopedic Class 1 888.4540 2019-04-29
HWR Driver, Prosthesis Orthopedic Class 1 888.4540 2019-04-29
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2019-09-23
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2019-09-23
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2019-09-23
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2019-09-23
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2019-09-23
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2022-09-30
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2019-09-23
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2019-09-23
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2019-09-23
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2019-09-23
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2019-09-23
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2015-01-15
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2019-09-23
NKG Posterior Cervical Screw System Orthopedic Class 2 888.3075 2019-09-23
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2019-09-23
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2019-09-23
MRW System, Facet Screw Spinal Device Unknown Class U N/A 2019-09-23
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-05-01
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2019-09-23
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2019-09-23
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2019-09-23
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2019-09-23
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2019-09-23
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 2019-09-23
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2019-09-23
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2019-09-23
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2019-09-23
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2019-09-23
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2019-09-23
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2019-09-23
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2019-09-23
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2019-09-23
NBH Accessories, Arthroscopic Orthopedic Class 1 888.1100 2018-08-15
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2022-11-04
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2022-11-04
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2019-09-23
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2019-09-23
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2019-09-23
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2019-09-23
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2019-09-23
HWT Template Orthopedic Class 1 888.4800 2019-04-29
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2019-09-23
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2019-09-23
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2019-09-23
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2018-08-26
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2019-09-23
PML Bone Cement, Posterior Screw Augmentation Orthopedic Class 2 888.3027 2019-09-23
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2019-09-23
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2019-09-23
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2019-09-23
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2019-09-23
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2019-09-23
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2019-09-23
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2024-05-02
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2024-05-02
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2019-09-23
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2019-09-23
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2019-09-23
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2019-09-23
NKG Posterior Cervical Screw System Orthopedic Class 2 888.3075 2020-12-17
GDF Guide, Needle, Surgical General, Plastic Surgery Class 1 878.4800 2019-09-23
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2019-09-23
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2019-09-23
PML Bone Cement, Posterior Screw Augmentation Orthopedic Class 2 888.3027 2023-12-01
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2023-12-01
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2019-09-23
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2019-09-23
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2019-09-23
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2019-09-23
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2024-12-03
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2024-12-03
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2024-12-03
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2024-12-03
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2024-12-03
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2024-12-03

Official Correspondent

No official correspondent registered.

US Agent Details

Lex Pearce Business: JABIL - NYPRO HEALTHCARE DIVISION Email: lex_pearce@jabil.com Phone: (505) 2030277

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
K041888 Signus Medizintechnik GmbH CURVED PEEK TETRIS SPINAL IMPLANT 2004-08-10
K211892 Arftx Medical, LLC ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages) 2022-10-06
K070082 Vertebration,Inc XY COR SPINAL IMPLANT FOR MINIMAL INVASIVE SPINAL SURGERY 2007-04-20
K051027 Surgicraft , Ltd. STALIF TT 2005-06-29
K161478 Xenco Medical, LLC Xenco Medical Posterior Cervical System 2016-09-06

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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1424263 Isomedix Operations, Inc. Libertyville, IL, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015831087. Last updated year: 2026. Please use registration number 3015831087 when referencing this establishment in official correspondence.
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