FDA Registration
Active
🇺🇸 United States
ALDEN TOOL COMPANY, INC.
Reg #: 3003525643
·
FEI: 3003525643
·
Expires 2026
Products
28
Proprietary Names
0
Establishment Types
1
Classifications
28
Registration Details
- Registration Name
- ALDEN TOOL COMPANY, INC.
- Registration Number
- 3003525643
- FEI Number
- 3003525643
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 199 New Park Dr
- City
- Berlin
- State
- CT
- ZIP
- 06037
- Country
- US
Owner / Operator
- Firm Name
- Alden Tool Company, Inc.
- Operator Number
- 10043828
- Address
- 199 New Park Drive
- City
- Berlin
- State
- CT
- Postal Code
- 06037
- Country
- US
- Correspondent
- John Killeen
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2026-03-02 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2026-03-02 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2026-03-02 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2026-03-02 |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2026-03-02 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2026-03-02 |
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2026-03-02 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2026-03-02 |
| Nail, Fixation, Bone | JDS | Class 2 | Orthopedic | No | 2026-03-02 |
| Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | OSH | Class 2 | Orthopedic | No | 2026-03-02 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2026-03-02 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2026-03-02 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2013-03-26 |
| Cutter, Surgical | FZT | Class 1 | General, Plastic Surgery | No | 2013-03-26 |
| Washer, Bolt Nut | HTN | Class 2 | Orthopedic | No | 2026-03-02 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2026-03-02 |
| Growing Rod System | PGM | Class 2 | Orthopedic | No | 2026-03-02 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2013-03-26 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2013-03-26 |
| Neurological Stereotaxic Instrument | HAW | Class 2 | Neurology | No | 2026-03-02 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2026-03-02 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | Class 2 | Orthopedic | No | 2026-03-02 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite | LXT | Class 2 | Orthopedic | No | 2026-03-02 |
| Rasp | HTR | Class 1 | General, Plastic Surgery | No | 2015-08-21 |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | Class 2 | Orthopedic | No | 2026-03-02 |
| Intervertebral Fusion Device With Bone Graft, Thoracic | PHM | Class 2 | Orthopedic | No | 2026-03-02 |
| Sacroiliac Joint Fixation | OUR | Class 2 | Orthopedic | No | 2026-03-02 |
| Passer, Wire, Orthopedic | HXI | Class 1 | Orthopedic | No | 2023-03-07 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)