Jabil Switzerland Manufacturing GmbH (Bettlach)

FDA Device Registration & Listing · Bettlach Solothurn, CH · Registration 3015882686

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
3015882686
FEI Number
3015882686
Entity Name
Jabil Switzerland Manufacturing GmbH (Bettlach)
City/State/Country
Bettlach Solothurn, CH
Establishment Address
Muracherstrasse 3, Bettlach Solothurn 2544, 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 90 Degree Screwdriver Synthes 2.4MM VA-LCP INTERCARPAL FUSION SYSTEM DePuy Synthes Tibial Nail Advanced System DePuy Synthes Locking Screws for Medullary Nails, 4 and 5 mm 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 ELBOW HINGE FIXATOR countersink Pelvic C-Clamp SYNTHES (USA) [SYNTHES] MINI EXTERNAL FIXATOR Screwdriver SCREWDRIVER (MULTIPLE BRANDS) chisel Case and Tray tray Bending Iron Instrument, Bending Or Contouring hook REAMER (MULTIPLE BRANDS) Orthopedic Wire Passer MINI LENGTHENING APPARATUS instrument Manual Orthopedic Instruments Instrument surgical instrument ORTHOPEDIC MANUAL SURGICAL INSTRUMENT CHIA PERCPASSER, DePuy Mitek Instrument Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment instrument, cutting, orthopedic TROCHANTERIC FIXATION NAIL (TFN) bender WIRE TWISTER HANDLE, SCALPEL Handle SPIKED WASHER Synthes 2.7mm LCP Ulna Osteotomy Plate System SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEM SYNTHES EXTERNAL FIXATION DEVICES, MR CONDITIONAL chisel Synthes MultiLoc Humeral Nailing System Stryker F1 Charger Module General Surgical Saw Blade TREPHINE guide Guide, Surgical Instrument Guide Block Drill Sleeve template Synthes Sternal ZipFix System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DZI Drill, Bone, Powered Dental Class 2 872.4120 2019-09-18
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 2020-11-03
JDS Nail, Fixation, Bone Orthopedic Class 2 888.3030 2020-11-03
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
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2019-04-30
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2019-03-08
LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite Orthopedic Class 2 888.3030 2019-09-23
HTC Pliers, Surgical General, Plastic Surgery Class 1 878.4800 2019-04-29
GFG Bit, Surgical General, Plastic Surgery Class 1 878.4820 2019-04-29
HWW Countersink Orthopedic Class 1 888.4540 2019-09-23
JEC Component, Traction, Invasive Orthopedic Class 2 888.3040 2019-09-23
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 2019-03-08
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2019-03-08
HXX Screwdriver Orthopedic Class 1 888.4540 2019-04-26
FZO Chisel, Surgical, Manual General, Plastic Surgery Class 1 878.4800 2018-08-13
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2019-04-29
HXP Instrument, Bending Or Contouring Orthopedic Class 1 888.4540 2019-04-29
KIK Hook, Bone General, Plastic Surgery Class 1 878.4800 2019-09-23
DZJ Driver, Wire, And Bone Drill, Manual Dental Class 2 872.4120 2019-04-29
HTO Reamer Orthopedic Class 1 888.4540 2019-03-08
HTF Curette General, Plastic Surgery Class 1 878.4800 2019-04-26
HXI Passer, Wire, Orthopedic Orthopedic Class 1 888.4540 2019-09-20
HWM Osteotome General, Plastic Surgery Class 1 878.4800 2019-04-29
MQN External Mandibular Fixator And/Or Distractor Dental Class 2 872.4760 2019-09-23
HWN Instrument, Compression Orthopedic Class 1 888.4540 2019-04-29
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2015-01-15
HXC Wrench Orthopedic Class 1 888.4540 2019-04-29
HSZ Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2019-04-30
HTZ Instrument, Cutting, Orthopedic General, Plastic Surgery Class 1 878.4800 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
HXS Twister, Wire Orthopedic Class 1 888.4540 2019-09-23
GDZ Handle, Scalpel General, Plastic Surgery Class 1 878.4800 2018-08-26
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2019-09-23
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2019-05-02
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-05-02
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
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2019-04-29
EML Chisel, Bone, Surgical Dental Class 1 872.4565 2019-09-23
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2019-09-19
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2019-05-02
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2019-04-29
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2018-08-26
GFF Bur, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4820 2018-08-10
GFA Blade, Saw, General & Plastic Surgery, Surgical General, Plastic Surgery Class 1 878.4820 2018-08-10
HWK Trephine Orthopedic Class 1 888.4540 2019-09-23
FZX Guide, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2019-03-08
HST Apparatus, Traction, Non-Powered Orthopedic Class 1 888.5850 2019-04-29
HWT Template Orthopedic Class 1 888.4800 2019-04-29
JDQ Cerclage, Fixation Orthopedic Class 2 888.3010 2019-09-20

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
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 3015882686. Last updated year: 2026. Please use registration number 3015882686 when referencing this establishment in official correspondence.
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