FDA Registration
Active
🇺🇸 United States
ARCH Medical Solutions - Elmhurst
Reg #: 1424434
·
FEI: 3002795782
·
Expires 2026
Products
35
Proprietary Names
7
Establishment Types
1
Classifications
35
Registration Details
- Registration Name
- ARCH Medical Solutions - Elmhurst
- Registration Number
- 1424434
- FEI Number
- 3002795782
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 612 W Lamont Rd
- City
- Elmhurst
- State
- IL
- ZIP
- 60126
- Country
- US
Owner / Operator
- Firm Name
- MedTorque, Inc.
- Operator Number
- 9038612
- Address
- 612 Lamont Road, --
- City
- Elmhurst
- State
- IL
- Postal Code
- 60126
- Country
- US
- Correspondent
- April E Schultz
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Probe | HXB | Class 1 | Orthopedic | No | 2016-11-18 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2013-02-04 |
| Prosthesis, Intervertebral Disc | MJO | Class 3 | Unknown | No | 2023-11-27 |
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2013-02-04 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2018-06-04 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2018-06-04 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2023-07-26 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2016-11-18 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2013-02-04 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2013-02-04 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2013-02-04 |
| Chisel, Surgical, Manual | FZO | Class 1 | General, Plastic Surgery | No | 2016-12-28 |
| Tap, Bone | HWX | Class 1 | Orthopedic | No | 2016-12-28 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2013-02-04 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2013-02-04 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2013-02-21 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | Class 2 | Orthopedic | No | 2013-02-04 |
| Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer | HSN | Class 2 | Orthopedic | No | 2013-02-04 |
| Extractor | HWB | Class 1 | Orthopedic | No | 2016-12-28 |
| Orthosis, Spine, Plate, Laminoplasty, Metal | NQW | Class 2 | Orthopedic | No | 2013-02-04 |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2023-08-31 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2023-08-31 |
| Pin, Fixation, Threaded | JDW | Class 2 | Orthopedic | No | 2013-02-04 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2016-12-28 |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | Class 2 | Orthopedic | No | 2013-02-04 |
| Impactor | HWA | Class 1 | Orthopedic | No | 2018-06-04 |
| Bender | HXW | Class 1 | Orthopedic | No | 2016-11-22 |
| Spinal Vertebral Body Replacement Device | MQP | Class 2 | Orthopedic | No | 2013-02-04 |
| Ankle Arthroplasty Implantation System | OYK | Class 2 | Orthopedic | No | 2013-02-04 |
| Instrument, Bending Or Contouring | HXP | Class 1 | Orthopedic | No | 2018-06-04 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2016-12-28 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2018-06-04 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2016-11-18 |
| Knife, Surgical | EMF | Class 1 | General, Plastic Surgery | No | 2013-02-04 |
| Instrument, Compression | HWN | Class 1 | Orthopedic | No | 2016-11-18 |
Proprietary Names
none available
NONE AVAILABLE
PRESTIGE LP CERVICAL DISC STREAMLINED INSTRUMENTS
n/a
intervertebral fusion device with bone graft, lumbar
Robotic Graft Delivery Instruments
orthopedic stereotaxic instrument
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)