FDA Registration
Active
🇺🇸 United States
DONSON MACHINE COMPANY
Reg #: 3004153896
·
FEI: 3004153896
·
Expires 2026
Products
62
Proprietary Names
72
Establishment Types
1
Classifications
62
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Registration Details
- Registration Name
- DONSON MACHINE COMPANY
- Registration Number
- 3004153896
- FEI Number
- 3004153896
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 12416 S KEDVALE AVE
- City
- ALSIP
- State
- IL
- ZIP
- 60803
- Country
- US
Owner / Operator
- Firm Name
- DONSON MACHINE COMPANY
- Operator Number
- 9057685
- Address
- 12416 S KEDVALE AVE, --
- City
- Alsip
- State
- IL
- Postal Code
- 60803
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2016-02-25 |
| Prosthesis, Hip, Femoral, Resurfacing | KXA | Class 2 | Orthopedic | No | 2012-12-07 |
| Spinal Vertebral Body Replacement Device | MQP | Class 2 | Orthopedic | No | 2013-01-31 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2012-12-17 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2013-01-31 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2021-04-05 |
| Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) | KWA | Class 3 | Orthopedic | No | 2021-04-05 |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | Class 2 | Orthopedic | No | 2021-04-05 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2021-04-05 |
| Prosthesis, Hip, Hemi-, Femoral, Metal | KWL | Class 2 | Orthopedic | No | 2021-04-05 |
| Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | OQG | Class 2 | Orthopedic | No | 2021-04-05 |
| Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) | JDL | Class 3 | Orthopedic | No | 2021-04-05 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | MEH | Class 2 | Orthopedic | No | 2021-04-05 |
| Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | KWZ | Class 2 | Orthopedic | No | 2021-04-05 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2021-04-05 |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2013-01-31 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish | MAY | Class 2 | Orthopedic | No | 2020-07-16 |
| Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | KWT | Class 2 | Orthopedic | No | 2020-02-24 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | KWS | Class 2 | Orthopedic | No | 2020-02-24 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2021-07-27 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2012-12-17 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2012-12-17 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2012-12-17 |
| Tamp | HXG | Class 1 | Orthopedic | No | 2021-06-07 |
| Template | HWT | Class 1 | Orthopedic | No | 2014-01-02 |
| Blade, Saw, General & Plastic Surgery, Surgical | GFA | Class 1 | General, Plastic Surgery | No | 2019-11-14 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2026-01-29 |
| Elevator | HTE | Class 1 | General, Plastic Surgery | No | 2021-06-07 |
| Prosthesis, Elbow, Constrained, Cemented | JDC | Class 2 | Orthopedic | No | 2020-01-07 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented | MBF | Class 2 | Orthopedic | No | 2020-01-07 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2013-01-31 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2013-01-31 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2020-01-21 |
| Curette | HTF | Class 1 | General, Plastic Surgery | No | 2021-06-07 |
| Shoulder Prosthesis, Reverse Configuration | PHX | Class 2 | Orthopedic | No | 2020-05-13 |
| Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented | OQI | Class 2 | Orthopedic | No | 2021-09-01 |
| Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented | OQH | Class 2 | Orthopedic | No | 2021-09-01 |
| Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive | PBI | Class 2 | Orthopedic | No | 2021-09-01 |
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | MBH | Class 2 | Orthopedic | No | 2018-10-29 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | OIY | Class 2 | Orthopedic | No | 2018-10-29 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2018-10-29 |
| Cerclage, Fixation | JDQ | Class 2 | Orthopedic | No | 2013-01-31 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2019-03-04 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2020-03-26 |
| Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | OSH | Class 2 | Orthopedic | No | 2013-01-31 |
| Spinal Vertebral Body Replacement Device - Cervical | PLR | Class 2 | Orthopedic | No | 2023-01-11 |
| Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | HSD | Class 2 | Orthopedic | No | 2026-04-22 |
| Impactor | HWA | Class 1 | Orthopedic | No | 2019-11-14 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | LWJ | Class 2 | Orthopedic | No | 2021-04-05 |
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2024-02-29 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented | PAO | Class 2 | Orthopedic | No | 2022-03-16 |
| Broach | HTQ | Class 1 | Orthopedic | No | 2019-11-14 |
| Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | KRO | Class 2 | Orthopedic | No | 2019-11-14 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2020-01-07 |
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2024-10-07 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2024-10-07 |
| Tap, Bone | HWX | Class 1 | Orthopedic | No | 2018-11-06 |
| Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer | HSN | Class 2 | Orthopedic | No | 2012-12-07 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2012-11-19 |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | Class 2 | Orthopedic | No | 2013-01-31 |
| Extractor | HWB | Class 1 | Orthopedic | No | 2019-11-14 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2019-12-19 |
Proprietary Names
RIO Partial Knee Application Instrumentation
Modular Unipolar
Santorini
Epic
Caspian, Mesa Mini, Denali Mini
TAPERLOC COMPLETE MICROPLASTY STEM
Chesapeake Lumbar
Arcos Modular Hip System
Augment Reamer Driver
Augment Glenoid Check Guide
Augment Reamer
Zimmer Biomet Instrument
Silverton
Telluride
Endoskeleton TL
Advantim patellar endmill
Advantim patellar template
Endoskeleton TO
Orthopedic Salvage System Instruments
G7 Revision Acetabular System
Endoskeleton TA
Comprehensive SRS
Comprehensive Instruments
Aleutian
Guide, Surgical Instruments
Range, Mesa, Denali, Natural Bridge
Endoskeleton TC
Endoskeleton TT
Comprehensive® Reverse Shoulder
CD Horizon Spinal System
Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
Persona Revision Knee System
Range Small Stature, Mesa
CoCr Wire, Nile
PERSONA REVISION KNEE SYSTM GENERAL
Pyrenees, Blue Ridge
ALPS Proximal Humerus Plating System
Durango
Range Pediatric
Zimmer Biomet Reverse Shoulder Prosethesis
Vail
Endoskeleton TA
TAPERLOC COMPLETE, SIZE 5 AND 6
Rosa Shoulder
Cayman Thoracolumbar
TAPERLOC COMPLETE, SIZE 4MM & XR 123
Pyrenees
COMPREHENSIVE REVERSE INST
Zimmer Nexel Total Elbow - Ulnar Bearing Tamp
Zimmer Nexel Total Elbow - Trephine Stabilizer S25/6
Zimmer Nexel Total Elbow - Trephine Stabilizer S24
Affixus Tibial and Antegrade Femoral Nailing System
Zimmer Trabecular Metal reverse shoulder system
Off-Axis
PSN Valgus Alignment Guide, W/UW
RIO Partial Knee Application Instrumentation - 111734
RIO Partial Knee Application Instrumentation - 111120
PSN Valgus Alignment Guide, UW/UW
PSN Valgus Alignment Guide, W/W
PSN Valgus Alignment Guide, UW/W
Comprehensive Shoulder System
ROSA® Stabilizer Tissue Deflector, 60mm
ROSA® Pin Stabilizer, 60mm
G7 Acetabular System
Chesapeake Cevical
Cayman Buttress
Aspen
Alliance Glenoid
Range, Ari
ROSA Shoulder System
Compress Instruments
Orthopedic Stereotaxic Instrument
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)