Jabil Switzerland Manufacturing GmbH (Hagendorf)

FDA Device Registration & Listing · Hagendorf Solothurn, CH · Registration 3015876273

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
3015876273
FEI Number
3015876273
Entity Name
Jabil Switzerland Manufacturing GmbH (Hagendorf)
City/State/Country
Hagendorf Solothurn, CH
Establishment Address
Im Bifang 6, Hagendorf Solothurn 4614, 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

tray, surgical DePuy Synthes Tibial Nail Advanced System DePuy Synthes Locking Screws for Medullary Nails, 4 and 5 mm TELIGEN System, TELIGEN Access Probe, TELIGEN Clear 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 SYNTHES (USA) RETROGRADE/ANTEGRADE FEMORAL NAIL SYSTEM Bit, Drill Universal Navigation Adaptor Set Discectomy Navigation Ready Instruments Universal Navigation Adaptor Set (UNAS) Symphony Navigation Ready Instruments REAMER (MULTIPLE BRANDS) Robotic Integration Instruments instrument, cutting, orthopedic impactor Synthes T-PAL Spacer T-PAL Ti Spacer Case and Tray tray template SYNTHES (USA) [SYNTHES] MINI EXTERNAL FIXATOR Stryker F1 Charger Module DePuy Synthes 2 Mm Quick Insertion Screws Synthes 90 Degree Screwdriver Synthes Dual-Opening USS tape GENERAL AND PLASTIC SURGERY CRSSSNAV Adaptor T-PAL chisel SYNFIX Evolution Universal Navigation Adaptor Set (UNAS) broach SYNTHES (U.S.A.) UNIVERSAL SPINAL PARALLEL CONNECTOR Synthes Sternal ZipFix System 2.4mm Variable Angle LCP Volar Rim Distal Radius System DePuy Synthes MatrixSTERNUM Fixation System SYNTHES(USA) SYNTHES HYBRID EXTERNA Orthopedic Wire Passer DePuy Synthes Femoral Neck System cutter Bending Iron Instrument, Bending Or Contouring extracter 3.5mm VA LCP Proximal TIbia Plate System Synthes Light Guide Screwdriver SCREWDRIVER (MULTIPLE BRANDS) VOLT Proximal Humerus 3.5 Plating System HANDLE, SCALPEL Handle Depth Gauge guide Guide, Surgical Instrument Guide Block Drill Sleeve SYNTHES VA LCP ANKLE TRAUMA SYSTEM

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LRP Tray, Surgical General, Plastic Surgery Class 1 878.4800 2019-09-20
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2020-11-03
JDS Nail, Fixation, Bone Orthopedic Class 2 888.3030 2020-11-03
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2019-04-30
HWR Driver, Prosthesis Orthopedic Class 1 888.4540 2019-04-29
HXG Tamp Orthopedic Class 1 888.4540 2019-04-29
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2024-07-09
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
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
HTW Bit, Drill Orthopedic Class 1 888.4540 2018-08-10
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2019-05-02
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2019-03-08
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2024-07-09
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2020-10-26
HTO Reamer Orthopedic Class 1 888.4540 2019-03-08
HXC Wrench Orthopedic Class 1 888.4540 2019-04-29
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2024-09-18
HTZ Instrument, Cutting, Orthopedic General, Plastic Surgery Class 1 878.4800 2019-04-29
HWA Impactor Orthopedic Class 1 888.4540 2019-04-29
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2019-09-20
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2019-09-19
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2019-04-29
HWT Template Orthopedic Class 1 888.4800 2019-04-29
JEY Plate, Bone Dental Class 2 872.4760 2019-04-30
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2019-05-02
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2019-05-02
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2018-08-26
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2019-09-19
DZI Drill, Bone, Powered Dental Class 2 872.4120 2019-09-18
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
HTE Elevator General, Plastic Surgery Class 1 878.4800 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
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2025-01-13
HTR Rasp General, Plastic Surgery Class 1 878.4800 2019-04-29
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2019-04-29
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2019-09-20
FZO Chisel, Surgical, Manual General, Plastic Surgery Class 1 878.4800 2018-08-13
KTZ Caliper Orthopedic Class 1 888.4150 2019-04-29
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2019-09-19
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2020-10-26
HTQ Broach Orthopedic Class 1 888.4540 2019-09-20
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
HTF Curette General, Plastic Surgery Class 1 878.4800 2019-04-26
JDQ Cerclage, Fixation Orthopedic Class 2 888.3010 2019-09-20
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2019-05-02
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2019-09-19
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-09-19
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2024-05-29
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2024-05-29
LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite Orthopedic Class 2 888.3030 2019-04-29
HXI Passer, Wire, Orthopedic Orthopedic Class 1 888.4540 2019-09-20
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2019-09-19
HXZ Cutter, Wire Orthopedic Class 1 888.4540 2019-09-20
HXP Instrument, Bending Or Contouring Orthopedic Class 1 888.4540 2019-04-29
HWB Extractor Orthopedic Class 1 888.4540 2019-03-08
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 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 2019-03-08
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2019-03-08
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2019-09-19
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-09-19
FQP Lamp, Operating-Room General, Plastic Surgery Class 2 878.4580 2019-09-20
HWX Tap, Bone Orthopedic Class 1 888.4540 2018-08-14
HXX Screwdriver Orthopedic Class 1 888.4540 2019-04-26
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 2024-10-30
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2019-05-02
GDZ Handle, Scalpel General, Plastic Surgery Class 1 878.4800 2018-08-26
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2019-04-29
HTJ Gauge, Depth Orthopedic Class 1 888.4300 2019-04-29
HXB Probe Orthopedic Class 1 888.4540 2019-04-29
HXW Bender Orthopedic Class 1 888.4540 2019-04-29
FZX Guide, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2019-03-08
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-04-30
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2019-04-30

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
K881095 CooperVision, Inc. KOI(TM) INSTRUMENT TRAYS 1988-04-06
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

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0036-2010 Alphatec Spine, Inc. 1
ROC Lumbar bolt caddy, Part Number: 81997-01-05. Sterilization container for ROC bolts/screws. Product is used to contain spinal implants.
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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015876273. Last updated year: 2026. Please use registration number 3015876273 when referencing this establishment in official correspondence.
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