FDA Registration
Active
🇺🇸 United States
AMERICAN MANUFACTURING AND ENGINEERING
Reg #: 3010197224
·
FEI: 3010197224
·
Expires 2026
Products
16
Proprietary Names
0
Establishment Types
1
Classifications
16
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Registration Details
- Registration Name
- AMERICAN MANUFACTURING AND ENGINEERING
- Registration Number
- 3010197224
- FEI Number
- 3010197224
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 506 Stump Rd
- City
- Montgomeryville
- State
- PA
- ZIP
- 18936
- Country
- US
Owner / Operator
- Firm Name
- American Manufacturing and Engineering
- Operator Number
- 10043997
- Address
- 506 Stump Road
- City
- Montgomeryville
- State
- PA
- Postal Code
- 18936
- Country
- US
- Correspondent
- Christine Knechel
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2023-01-16 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2013-04-16 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2013-04-16 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2013-04-16 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2013-04-16 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2023-01-16 |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | Class 2 | Orthopedic | No | 2023-01-16 |
| Spinal Vertebral Body Replacement Device | MQP | Class 2 | Orthopedic | No | 2025-01-16 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2025-01-16 |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2025-01-16 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2023-01-16 |
| Neurological Stereotaxic Instrument | HAW | Class 2 | Neurology | No | 2023-01-16 |
| Washer, Bolt Nut | HTN | Class 2 | Orthopedic | No | 2023-01-16 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2023-01-16 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2023-01-16 |
| Sacroiliac Joint Fixation | OUR | Class 2 | Orthopedic | No | 2023-01-16 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)