FDA Registration
Active
🇺🇸 United States
AMERICAN MANUFACTURING AND ENGINEERING
Reg #: 3010197224
·
FEI: 3010197224
·
Expires 2025
Products
1
Proprietary Names
0
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- AMERICAN MANUFACTURING AND ENGINEERING
- Registration Number
- 3010197224
- FEI Number
- 3010197224
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 506 Stump Rd
- City
- Montgomeryville
- State
- PA
- ZIP
- 18936
- Country
- US
Regulatory Submissions
- 510(k) Number
- K081391
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 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)