FRUEH VERPACKUNGSTECHNIK AG

FDA Device Registration & Listing · Fehraltorf Zurich, CH · Registration 3010363503

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
3010363503
FEI Number
3010363503
Entity Name
FRUEH VERPACKUNGSTECHNIK AG
City/State/Country
Fehraltorf Zurich, CH
Establishment Address
Allmendstrasse 47, Fehraltorf Zurich 8320, CH
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Frueh Verpackungstechnik AG (Owner Number: 10043460)
Owner / Operator Contact Address
Allmendstrasse 47, Fehraltorf, CH-ZH 8320, CH
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

DePuy Synthes Tibial Nail Advanced System DePuy Synthes Locking Screws for Medullary Nails, 4 and 5 mm Electric Pen Drive System SL-Plus MIA Plate, fixation, bone 4.5 mm VA-LCP Curved Condylar Plate System 3.5 mm LCP Hook Plate Prodisc L Fragment Dynamic Compression Locking (DCL) System Synthes Variable Angle LCP Elbow System Contact implant, healing cap included SPI ELEMENT Univers Glenoid Poly with keel Multiloc Proximal Humeral Nailing System Plate, fixation, bone Screw, fixation,bone Tomofix Osteotomy System Zero-P SYNTHES SMALL EXTERNAL FIXATION SYSTEM, SYNTHES LARGE EXTERNAL FIXATION SYSTEM Screw, fixation,bone 2.4 mm VA-LCP Intercarpal Fusion System Plate, fixation, bone SDS 1.2 Dental Implant Angular Stable Locking System (ASLS) Implant Endosseous Root-Form plate, fixation, bone 2.4 mm VA-LCP Volar Rim Distal Radius System Synthes 4.5 mm VA-LCP Curved Condylar System Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component SYNTHES LARGE EXTERNAL FIXATION, MR CONDITIONAL Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Syncage Evolution Spacer SAW Trochanteric Fixation Nail-Advanced System 2.4 mm VA-LCP Dorsal Distal Radius Plates Element implant, healing cap included Craniofacial Plate and Screw System DePuy Synthes VOLT Small Fragment Plating System DePuy Synthes VOLT Mini Fragment Plating System Cranial Flap Tube Clamp Prontosa Wound Irrigation Solution Adapter Instrument, Compression Mi1000 Implant Template Zero -P Varible Angle Blade, Saw,General Plastic Surgery, Surgical Thoracolumbosacral Pedicle Screw System Spinal Vertebral Body Replacement Device Prodisc C Multiloc Humeral Nailing System Plate, fixation, bone Evolution Secured Spacer System 4.5mm and 6.5 mm Headless Compression screws Variable Angle Locking Hand system Guide, surgical, instrument Tyber Medical HCS CIM 3.3 mm ND Affixus Humerus Nail Locking Hand Plates Polarcup Variable Angle Locking Hand System DePuy Synthes 2.7mm Straight And 2.7mm Adaption Plates (Modular Mini Fragment LCP System) Synthes 3.5 mm VA-LCP Proximal Tibia Plates System Sternal Fixation System-Line Extension Implant Endosseous Root-Form Zero-P Varable Angle (VA) 2.7 mm LCP ULNA Osteotomy System Plate,fixation, bone 2.4mm/2.7 mm Variable Angle LCP Forefoot/Midfoot System Contact Implant, healing cap included Variable Angle LCP Elbow System VA Clavicle System Univers Glenoid Poly with keel, extra large Sternal Fixation System Lateral Entry Femoral Nail System Bone Cement, Posterior Screw Augmentation Zero-P Natural Plate System 2.4 mm VA-LCP Two-Column Narrow Volar Distal Radius Pediatric LCP HIP Plate Orthopedic Manual Surgical Instrument IB-Stim HYDROXYAPATITE (HA) COATED SCHANZ SCREWS Polarstem

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-07-17
JDS Nail, Fixation, Bone Orthopedic Class 2 888.3030 2021-07-17
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2019-12-13
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2019-12-13
HBE Drills, Burrs, Trephines & Accessories (Simple, Powered) Neurology Class 2 882.4310 2017-03-21
ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece Ear, Nose, Throat Class 2 874.4250 2017-03-21
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2017-03-21
DZI Drill, Bone, Powered Dental Class 2 872.4120 2017-03-21
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2017-02-23
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2025-02-27
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2017-06-09
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2024-10-24
JDP Condylar Plate Fixation Implant Orthopedic Class 2 888.3030 2017-03-21
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2017-03-21
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2014-04-03
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2024-09-09
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2024-10-24
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2024-10-24
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2017-03-21
MJO Prosthesis, Intervertebral Disc Unknown Class 3 N/A 2019-12-13
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2017-03-22
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2017-03-21
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2017-02-14
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2019-01-18
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2017-02-14
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2017-03-21
PML Bone Cement, Posterior Screw Augmentation Orthopedic Class 2 888.3027 2023-01-18
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2023-01-18
NKG Posterior Cervical Screw System Orthopedic Class 2 888.3075 2025-12-04
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2025-12-04
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2017-06-09
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2017-06-09
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2017-03-21
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2017-03-21
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2024-08-19
PML Bone Cement, Posterior Screw Augmentation Orthopedic Class 2 888.3027 2024-08-19
PLR Spinal Vertebral Body Replacement Device - Cervical Orthopedic Class 2 888.3060 2024-08-19
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2024-08-19
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2022-01-19
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2024-10-24
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2017-06-09
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2019-12-13
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2019-12-13
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2017-03-21
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2017-03-21
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2017-06-09
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2019-12-13
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2019-12-13
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2017-03-21
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2017-02-13
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-04-19
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2017-03-21
PGM Growing Rod System Orthopedic Class 2 888.3070 2026-01-22
JDP Condylar Plate Fixation Implant Orthopedic Class 2 888.3030 2017-03-21
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2017-03-21
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2018-05-03
PML Bone Cement, Posterior Screw Augmentation Orthopedic Class 2 888.3027 2024-08-19
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2024-08-19
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2022-01-19
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2018-05-03
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2024-10-24
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2017-03-22
HSO Saw General, Plastic Surgery Class 1 878.4800 2017-06-13
HTW Bit, Drill Orthopedic Class 1 888.4540 2021-04-29
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2017-03-21
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2017-03-21
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2017-02-14
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2022-08-29
JEY Plate, Bone Dental Class 2 872.4760 2017-03-21
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2024-07-16
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2024-07-16
GXN Plate, Cranioplasty, Preformed, Non-Alterable Neurology Class 2 882.5330 2017-03-22
FRO Dressing, Wound, Drug Unknown Class U N/A 2020-02-07
HWN Instrument, Compression Orthopedic Class 1 888.4540 2017-06-13
PGQ Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification Unknown Class 3 N/A 2017-02-14
MCM Implant, Cochlear Unknown Class 3 N/A 2017-02-14
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2017-03-22
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2024-10-09
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2025-02-27
GFA Blade, Saw, General & Plastic Surgery, Surgical General, Plastic Surgery Class 1 878.4820 2017-06-13
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2024-10-24
JDQ Cerclage, Fixation Orthopedic Class 2 888.3010 2024-10-24
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2024-10-24
JDP Condylar Plate Fixation Implant Orthopedic Class 2 888.3030 2024-10-24
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2014-04-02
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2019-07-02
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2020-06-04
PLR Spinal Vertebral Body Replacement Device - Cervical Orthopedic Class 2 888.3060 2020-06-04
MJO Prosthesis, Intervertebral Disc Unknown Class 3 N/A 2019-12-13
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2024-08-19
PML Bone Cement, Posterior Screw Augmentation Orthopedic Class 2 888.3027 2024-08-19
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2017-03-21
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2017-06-09
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2017-03-22
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2017-03-21
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2023-11-14
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2023-11-14
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2017-03-21
FZX Guide, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2017-06-13
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2019-12-13
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2017-02-14
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2017-02-14
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2019-03-26
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2025-01-07
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2025-01-07
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2017-03-22
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2017-02-23
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2017-03-21
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2017-03-21
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-06-24
PML Bone Cement, Posterior Screw Augmentation Orthopedic Class 2 888.3027 2025-03-11
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-03-11
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2013-02-26
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2024-10-24
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2017-03-21
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2017-03-21
HWB Extractor Orthopedic Class 1 888.4540 2025-02-03
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2024-08-19
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2024-08-19
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2017-02-13
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2024-10-24
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2024-10-24
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2017-03-21
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2017-03-21
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2017-03-21
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2017-06-09
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2017-03-21
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2013-03-06
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2017-02-14
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic Class 2 888.3390 2014-04-02
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2014-04-02
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2014-04-02
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2017-03-21
FRO Dressing, Wound, Drug Unknown Class U N/A 2014-06-03
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-04-19
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2017-02-14
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2013-03-06
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2017-03-21
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2017-03-21
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2017-03-21
PML Bone Cement, Posterior Screw Augmentation Orthopedic Class 2 888.3027 2020-10-29
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2020-10-29
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2017-03-21
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2017-03-21
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2017-03-21
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2017-03-21
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2017-03-21
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2017-06-13
BWK Stimulator, Electro-Acupuncture Unknown Class U N/A 2017-02-24
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-01-19
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2025-01-07
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2025-01-07
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2017-02-23
LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3360 2017-02-23
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2017-02-23
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic Class 2 888.3390 2017-02-23

Official Correspondent

Regina Bruggisser

US Agent Details

Jeffrey Zoleta Business: Fruh Packaging Inc. Email: jzoleta@fruh.us Phone: (267) 4993244

Related Public Records

Same Entity

Frueh Verpackungstechnik AG
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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 3010363503. Last updated year: 2026. Please use registration number 3010363503 when referencing this establishment in official correspondence.
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