FDA Registration
Active
🇺🇸 United States
ARCH Medical Solutions - Warsaw
Reg #: 3009971621
·
FEI: 3009971621
·
Expires 2026
Products
57
Proprietary Names
0
Establishment Types
1
Classifications
57
Registration Details
- Registration Name
- ARCH Medical Solutions - Warsaw
- Registration Number
- 3009971621
- FEI Number
- 3009971621
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 2070 N Cessna Rd
- City
- Warsaw
- State
- IN
- ZIP
- 46582
- Country
- US
Owner / Operator
- Firm Name
- Alpha Manufacturing & Design, LLC.
- Operator Number
- 10042381
- Address
- 2070 North Cessna Road
- City
- Warsaw
- State
- IN
- Postal Code
- 46582
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2020-07-16 |
| Cerclage, Fixation | JDQ | Class 2 | Orthopedic | No | 2020-07-16 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2020-07-16 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2024-02-13 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2024-02-13 |
| Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | KWT | Class 2 | Orthopedic | No | 2020-07-16 |
| Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer | HSN | Class 2 | Orthopedic | No | 2013-01-23 |
| Pin, Fixation, Smooth | HTY | Class 2 | Orthopedic | No | 2019-03-26 |
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2020-07-16 |
| Bit, Surgical | GFG | Class 1 | General, Plastic Surgery | No | 2020-07-16 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2012-11-21 |
| Bender | HXW | Class 1 | Orthopedic | No | 2012-11-21 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | Class 2 | Orthopedic | No | 2012-11-21 |
| Instrument, Compression | HWN | Class 1 | Orthopedic | No | 2019-09-19 |
| Mallet | HXL | Class 1 | General, Plastic Surgery | No | 2023-07-13 |
| Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | OSH | Class 2 | Orthopedic | No | 2016-11-23 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2016-11-23 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2016-11-23 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2016-11-23 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2022-03-03 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2012-11-21 |
| Passer | HWQ | Class 1 | Orthopedic | No | 2019-09-19 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2012-11-21 |
| Starter, Bone Screw | HWD | Class 1 | Orthopedic | No | 2012-11-21 |
| Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained | JWJ | Class 2 | Orthopedic | No | 2024-09-24 |
| Hook, Bone | KIK | Class 1 | General, Plastic Surgery | No | 2019-08-27 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2023-01-19 |
| Tamp | HXG | Class 1 | Orthopedic | No | 2023-07-13 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2019-08-13 |
| Extractor | HWB | Class 1 | Orthopedic | No | 2012-11-21 |
| Hammer, Surgical | FZY | Class 1 | General, Plastic Surgery | No | 2023-01-17 |
| Rongeur | HTX | Class 1 | Orthopedic | No | 2021-08-25 |
| Holder, Needle; Orthopedic | HXK | Class 1 | Orthopedic | No | 2013-05-22 |
| Impactor | HWA | Class 1 | Orthopedic | No | 2012-11-21 |
| Clamp | HXD | Class 1 | General, Plastic Surgery | No | 2026-04-30 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2012-11-21 |
| Template | HWT | Class 1 | Orthopedic | No | 2012-11-21 |
| Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | HSD | Class 2 | Orthopedic | No | 2019-09-19 |
| Countersink | HWW | Class 1 | Orthopedic | No | 2012-11-21 |
| Shoulder Prosthesis, Reverse Configuration | PHX | Class 2 | Orthopedic | No | 2024-09-12 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2012-11-21 |
| Passer, Wire, Orthopedic | HXI | Class 1 | Orthopedic | No | 2012-11-21 |
| Cutter, Surgical | FZT | Class 1 | General, Plastic Surgery | No | 2023-07-13 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2024-01-11 |
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | Class 2 | Orthopedic | No | 2023-07-13 |
| Wrench | HXC | Class 1 | Orthopedic | No | 2012-11-21 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2019-05-07 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 2018-12-27 |
| Tap, Bone | HWX | Class 1 | Orthopedic | No | 2012-11-21 |
| Chisel, Surgical, Manual | FZO | Class 1 | General, Plastic Surgery | No | 2023-01-17 |
| Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment | KIJ | Class 1 | General, Plastic Surgery | No | 2024-09-10 |
| Washer, Bolt Nut | HTN | Class 2 | Orthopedic | No | 2020-07-16 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2019-08-27 |
| Instrument, Bending Or Contouring | HXP | Class 1 | Orthopedic | No | 2012-11-21 |
| Probe | HXB | Class 1 | Orthopedic | No | 2019-08-27 |
| Staple, Fixation, Bone | JDR | Class 2 | Orthopedic | No | 2024-09-25 |
| Driver, Prosthesis | HWR | Class 1 | Orthopedic | No | 2012-11-21 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)