FDA Registration
Active
🇨🇭 Switzerland
FRUEH VERPACKUNGSTECHNIK AG
Reg #: 3010363503
·
FEI: 3010363503
·
Expires 2026
Products
52
Proprietary Names
87
Establishment Types
2
Classifications
52
Registration Details
- Registration Name
- FRUEH VERPACKUNGSTECHNIK AG
- Registration Number
- 3010363503
- FEI Number
- 3010363503
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Allmendstrasse 47
- City
- Fehraltorf Zurich
- Country
- CH
Owner / Operator
- Firm Name
- Frueh Verpackungstechnik AG
- Operator Number
- 10043460
- Address
- Allmendstrasse 47
- City
- Fehraltorf
- State
- Zurich
- Postal Code
- 8320
- Country
- CH
- Correspondent
- Regina Bruggisser
US Agent
- Business Name
- Fruh Packaging Inc.
- Contact Name
- Jeffrey Zoleta
- Address
- 240 Sierra Dr
- City
- Exton
- State
- PA
- ZIP
- 19341
- Country
- US
- [email protected]
- Phone
- 267 4993244
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2021-07-17 |
| Nail, Fixation, Bone | JDS | Class 2 | Orthopedic | No | 2021-07-17 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2019-12-13 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2019-12-13 |
| Drills, Burrs, Trephines & Accessories (Simple, Powered) | HBE | Class 2 | Neurology | No | 2017-03-21 |
| Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | ERL | Class 2 | Ear, Nose, Throat | No | 2017-03-21 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2017-03-21 |
| Drill, Bone, Powered | DZI | Class 2 | Dental | No | 2017-03-21 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2017-02-23 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2017-06-09 |
| Condylar Plate Fixation Implant | JDP | Class 2 | Orthopedic | No | 2017-03-21 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2014-04-03 |
| Abutment, Implant, Dental, Endosseous | NHA | Class 2 | Dental | No | 2024-09-09 |
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2024-10-24 |
| Prosthesis, Intervertebral Disc | MJO | Class 3 | Unknown | No | 2019-12-13 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | Class 2 | Orthopedic | No | 2017-03-22 |
| Implant, Endosseous, Root-Form | DZE | Class 2 | Dental | No | 2017-02-14 |
| Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | HSD | Class 2 | Orthopedic | No | 2017-02-14 |
| Bone Cement, Posterior Screw Augmentation | PML | Class 2 | Orthopedic | No | 2023-01-18 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2023-01-18 |
| Posterior Cervical Screw System | NKG | Class 2 | Orthopedic | No | 2025-12-04 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2025-12-04 |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | Class 2 | Orthopedic | No | 2017-03-21 |
| Spinal Vertebral Body Replacement Device | MQP | Class 2 | Orthopedic | No | 2024-08-19 |
| Spinal Vertebral Body Replacement Device - Cervical | PLR | Class 2 | Orthopedic | No | 2024-08-19 |
| Growing Rod System | PGM | Class 2 | Orthopedic | No | 2026-01-22 |
| Saw | HSO | Class 1 | General, Plastic Surgery | No | 2017-06-13 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2021-04-29 |
| Plate, Bone | JEY | Class 2 | Dental | No | 2017-03-21 |
| Plate, Cranioplasty, Preformed, Non-Alterable | GXN | Class 2 | Neurology | No | 2017-03-22 |
| Dressing, Wound, Drug | FRO | Class U | Unknown | No | 2020-02-07 |
| Instrument, Compression | HWN | Class 1 | Orthopedic | No | 2017-06-13 |
| Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification | PGQ | Class 3 | Unknown | No | 2017-02-14 |
| Implant, Cochlear | MCM | Class 3 | Unknown | No | 2017-02-14 |
| Blade, Saw, General & Plastic Surgery, Surgical | GFA | Class 1 | General, Plastic Surgery | No | 2017-06-13 |
| Cerclage, Fixation | JDQ | Class 2 | Orthopedic | No | 2024-10-24 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2024-08-19 |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2017-03-22 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2017-06-13 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2017-02-23 |
| Extractor | HWB | Class 1 | Orthopedic | No | 2025-02-03 |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | Class 2 | Orthopedic | No | 2014-04-02 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2014-04-02 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2017-06-13 |
| Stimulator, Electro-Acupuncture | BWK | Class U | Unknown | No | 2017-02-24 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | LWJ | Class 2 | Orthopedic | No | 2017-02-23 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | MEH | Class 2 | Orthopedic | No | 2017-02-23 |
| Bit, Surgical | GFG | Class 1 | General, Plastic Surgery | No | 2017-06-13 |
| Instrument, Surgical, Sonic And Accessory/Attachment | JDX | Class 2 | Orthopedic | No | 2017-02-24 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2017-06-13 |
| Template | HWT | Class 1 | Orthopedic | No | 2018-07-10 |
| Software For Diagnosis/Treatment | OSN | Class 2 | Orthopedic | No | 2022-01-19 |
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
Screw, fixation,bone
Tomofix Osteotomy System
Zero-P
SYNTHES SMALL EXTERNAL FIXATION SYSTEM, SYNTHES LARGE EXTERNAL FIXATION SYSTEM
2.4 mm VA-LCP Intercarpal Fusion System
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
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
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
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
Bit,Surgical
Neuro Plate and Screw System
Rod, fixation, intramedullary and accessories
LCP Distal Femur Plates
Piezotome System
Screwdriver
Synthes Zero-P
Synthes VA LCP Ankle Trauma Trauma System
DePuy Synthes MAXFRAME Multi-Axial Correction System
Appliance, fixation, spinal intervertebral body
Synthes (USA) 3.5 mm Locking Attachment Plates
2.4 mm VA-LCP Two-Column Volar Distal Radius Plates
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Sterilize Medical Device for Another Party (Contract Sterilizer)