Jabil Switzerland Manufacturing GmbH (Balsthal)

FDA Device Registration & Listing · Balsthal Solothurn, CH · Registration 3015877656

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
3015877656
FEI Number
3015877656
Entity Name
Jabil Switzerland Manufacturing GmbH (Balsthal)
City/State/Country
Balsthal Solothurn, CH
Establishment Address
Dornacherstrasse 20, Balsthal Solothurn CH-4710, 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

SYNTHES (USA) RETROGRADE/ANTEGRADE FEMORAL NAIL SYSTEM Synthes Curvilinear Distraction System instrument Synthes 2.4MM VA-LCP INTERCARPAL FUSION SYSTEM screw Smooth threaded metallic bone fix SYNTHES ANATOMICAL LOCKING PLATE SYSTEM DePuy Synthes Femoral Neck System Bending Iron Instrument, Bending Or Contouring Synthes 2.7mm LCP Ulna Osteotomy Plate System Forceps instrument Cannulated Reduction Tool Bit, Drill extracter Synthes Cortical Screws SYNTHES (USA) 2.4 MM LCP WRIST PLATE

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2019-03-08
MQN External Mandibular Fixator And/Or Distractor Dental Class 2 872.4760 2019-09-23
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2019-04-29
HWN Instrument, Compression Orthopedic Class 1 888.4540 2019-04-29
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 2019-05-02
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-05-02
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
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2019-05-01
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2019-09-19
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-09-19
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2019-09-19
HXP Instrument, Bending Or Contouring Orthopedic Class 1 888.4540 2019-04-29
JDS Nail, Fixation, Bone Orthopedic Class 2 888.3030 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
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2019-05-02
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2019-05-02
HTD Forceps General, Plastic Surgery Class 1 878.4800 2019-04-29
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-04-30
HTW Bit, Drill Orthopedic Class 1 888.4540 2018-08-10
HWB Extractor Orthopedic Class 1 888.4540 2019-03-08
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2019-04-28
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2019-04-29
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 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
K040336 Synthes (Usa) SYNTHES (USA) LATERAL ENTRY FEMORAL NAIL SYSTEM 2004-04-12
K083648 Efratgo, Ltd. HI Tech Bio-Surgical GOTFRIED PHYSIOLOGICAL HIP (PH) NAIL 2009-05-14
K192312 Zimmer GmbH Zimmer Natural Nail System Cephalomedullary Nails 2019-10-11
K002057 Biomet Orthopedics, Inc. BROOKER TIBIA NAILS 2000-10-04
K033476 Howmedica Osteonics Corp. MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM 2004-01-20

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 3015877656. Last updated year: 2026. Please use registration number 3015877656 when referencing this establishment in official correspondence.
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