FDA Registration
Active
🇺🇸 United States
ARCH Medical Solutions - Memphis
Reg #: 3009973505
·
FEI: 3009973505
·
Expires 2026
Products
101
Proprietary Names
15
Establishment Types
1
Classifications
101
Registration Details
- Registration Name
- ARCH Medical Solutions - Memphis
- Registration Number
- 3009973505
- FEI Number
- 3009973505
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 7580 BARTLETT CORPORATE DR
- City
- BARTLETT
- State
- TN
- ZIP
- 38133
- Country
- US
Owner / Operator
- Firm Name
- Arch Medical Solutions
- Operator Number
- 10042635
- Address
- 7580 Bartlett Corporate Dr.
- City
- Bartlett
- State
- TN
- Postal Code
- 38133
- Country
- US
- Correspondent
- Garry M Smith
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2022-02-07 |
| Elevator | HTE | Class 1 | General, Plastic Surgery | No | 2012-12-14 |
| Spinal Vertebral Body Replacement Device | MQP | Class 2 | Orthopedic | No | 2025-01-17 |
| Spinal Vertebral Body Replacement Device - Cervical | PLR | Class 2 | Orthopedic | No | 2025-01-17 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2025-01-16 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2025-01-16 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2025-01-16 |
| Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | OSH | Class 2 | Orthopedic | No | 2025-01-16 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2025-01-16 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2025-01-16 |
| File | HTP | Class 1 | Orthopedic | No | 2012-12-14 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2019-12-17 |
| Drills, Burrs, Trephines & Accessories (Simple, Powered) | HBE | Class 2 | Neurology | No | 2022-12-12 |
| Intervertebral Fusion Device With Bone Graft, Thoracic | PHM | Class 2 | Orthopedic | No | 2025-01-16 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2012-12-14 |
| Tamp | HXG | Class 1 | Orthopedic | No | 2012-12-14 |
| Pin, Fixation, Smooth | HTY | Class 2 | Orthopedic | No | 2020-06-05 |
| Device, Fixation, Proximal Femoral, Implant | JDO | Class 2 | Orthopedic | No | 2020-06-05 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2020-06-05 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2020-06-05 |
| Specula Accessories | FXG | Class 1 | General, Plastic Surgery | No | 2012-12-14 |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2025-01-16 |
| Blade, Scalpel | GES | Class 1 | General, Plastic Surgery | No | 2012-12-14 |
| Posterior Cervical Screw System | NKG | Class 2 | Orthopedic | No | 2022-02-07 |
| Filler, Bone Void, Calcium Compound | MQV | Class 2 | Orthopedic | No | 2025-01-17 |
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2025-01-16 |
| Electromyograph, Diagnostic | IKN | Class 2 | Physical Medicine | No | 2025-01-16 |
| Stimulator, Nerve | ETN | Class 2 | Ear, Nose, Throat | No | 2025-01-16 |
| System, X-Ray, Fluoroscopic, Image-Intensified | JAA | Class 2 | Radiology | No | 2025-01-16 |
| Neurosurgical Nerve Locator | PDQ | Class 2 | Ear, Nose, Throat | No | 2025-01-16 |
| Neurological Stereotaxic Instrument | HAW | Class 2 | Neurology | No | 2025-01-16 |
| Stimulator, Electrical, Evoked Response | GWF | Class 2 | Neurology | No | 2025-01-16 |
| Interventional Fluoroscopic X-Ray System | OWB | Class 2 | Radiology | No | 2025-01-16 |
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2019-12-13 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2020-06-05 |
| Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | HSX | Class 2 | Orthopedic | No | 2020-06-05 |
| Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | NPJ | Class 2 | Orthopedic | No | 2020-06-05 |
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | MBH | Class 2 | Orthopedic | No | 2020-06-05 |
| Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | KRO | Class 2 | Orthopedic | No | 2020-06-05 |
| Prosthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Polymer | KRQ | Class 2 | Orthopedic | No | 2020-06-05 |
| Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | HRY | Class 2 | Orthopedic | No | 2020-06-05 |
| Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer | KRR | Class 2 | Orthopedic | No | 2020-06-05 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2012-12-14 |
| Bone Fixation Cerclage, Sublaminar | OWI | Class 2 | Orthopedic | No | 2025-01-16 |
| Prosthesis, Intervertebral Disc | MJO | Class 3 | Unknown | No | 2025-01-17 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2012-12-14 |
| Tap, Bone | HWX | Class 1 | Orthopedic | No | 2012-12-14 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2012-12-14 |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | Class 2 | Orthopedic | No | 2025-01-16 |
| Chisel (Osteotome) | KDG | Class 1 | General, Plastic Surgery | No | 2012-12-14 |
| Pusher, Socket | HXO | Class 1 | Orthopedic | No | 2012-12-14 |
| Broach | HTQ | Class 1 | Orthopedic | No | 2012-12-14 |
| Curette | HTF | Class 1 | General, Plastic Surgery | No | 2012-12-14 |
| Template | HWT | Class 1 | Orthopedic | No | 2012-12-14 |
| Growing Rod System- Magnetic Actuation | PGN | Class 2 | Orthopedic | No | 2025-01-16 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2012-12-14 |
| Stimulator, Auditory, Evoked Response | GWJ | Class 2 | Neurology | No | 2020-07-10 |
| Orthosis, Spine, Plate, Laminoplasty, Metal | NQW | Class 2 | Orthopedic | No | 2025-01-16 |
| Hook, Surgical, General & Plastic Surgery | GDG | Class 1 | General, Plastic Surgery | No | 2012-12-14 |
| Bone Cement, Posterior Screw Augmentation | PML | Class 2 | Orthopedic | No | 2025-01-16 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2025-01-16 |
| Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | KWT | Class 2 | Orthopedic | No | 2017-12-01 |
| Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | HSD | Class 2 | Orthopedic | No | 2017-12-01 |
| Osteotome | HWM | Class 1 | General, Plastic Surgery | No | 2012-12-14 |
| Awl | HWJ | Class 1 | Orthopedic | No | 2012-12-14 |
| Pin, Fixation, Threaded | JDW | Class 2 | Orthopedic | No | 2020-06-05 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2012-12-14 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2025-01-17 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2012-12-14 |
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2025-01-17 |
| Nail, Fixation, Bone | JDS | Class 2 | Orthopedic | No | 2025-01-17 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2020-06-05 |
| Mesh, Surgical, Acetabular, Hip, Prosthesis | JDJ | Class 2 | General, Plastic Surgery | No | 2020-06-05 |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | Class 2 | Orthopedic | No | 2020-06-05 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2020-06-05 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2020-06-05 |
| Prosthesis, Hip, Hemi-, Femoral, Metal Ball | LZY | Class 2 | Orthopedic | No | 2020-06-05 |
| Cerclage, Fixation | JDQ | Class 2 | Orthopedic | No | 2020-06-05 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | LWJ | Class 2 | Orthopedic | No | 2020-06-05 |
| Prosthesis, Hip, Femoral Component, Cemented, Metal | JDG | Class 2 | Orthopedic | No | 2020-06-05 |
| Prosthesis, Hip, Hemi-, Femoral, Metal | KWL | Class 2 | Orthopedic | No | 2020-06-05 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | MEH | Class 2 | Orthopedic | No | 2020-06-05 |
| Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | KWZ | Class 2 | Orthopedic | No | 2020-06-05 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous | MBL | Class 2 | Orthopedic | No | 2020-06-05 |
| Cannula, Surgical, General & Plastic Surgery | GEA | Class 1 | General, Plastic Surgery | No | 2012-12-14 |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | Class 2 | General Hospital | No | 2025-01-16 |
| Hammer, Surgical | FZY | Class 1 | General, Plastic Surgery | No | 2012-12-14 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2012-12-14 |
| Wrench | HXC | Class 1 | Orthopedic | No | 2012-12-14 |
| Orthopedic Augmented Reality | SBF | Class 2 | Neurology | No | 2023-03-27 |
| Light, Surgical, Fiberoptic | FST | Class 2 | General, Plastic Surgery | No | 2025-01-16 |
| Caliper | KTZ | Class 1 | Orthopedic | No | 2012-12-14 |
| Impactor | HWA | Class 1 | Orthopedic | No | 2012-12-14 |
| Bender | HXW | Class 1 | Orthopedic | No | 2012-12-14 |
| Accessories, Arthroscopic | NBH | Class 1 | Orthopedic | No | 2012-12-14 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | Class 2 | Orthopedic | No | 2020-06-05 |
| Cuff, Tracheal Tube, Inflatable | BSK | Class 2 | Anesthesiology | No | 2025-01-16 |
| Tube, Tracheal (W/Wo Connector) | BTR | Class 2 | Anesthesiology | No | 2025-01-16 |
| Spinous Process Plate | PEK | Class 2 | Orthopedic | No | 2025-01-16 |
| Probe | HXB | Class 1 | Orthopedic | No | 2012-12-14 |
| Sacroiliac Joint Fixation | OUR | Class 2 | Orthopedic | No | 2022-02-07 |
Proprietary Names
General Surgical Instrument
Globus
EXCELSIUS GPS
CD Horizon (TM) Spinal System
Perimeter Interbody Fusion Device
Smith & Nephew
CREO Threaded Stabilization System
QUARTEX
Excelsius GPS
Clydesdale Spinal System
CD Horizon Spinal System
Catalyst CSR Shoulder System
HOLO Portal
VuePoint II
Verte-Stack
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)