FDA Registration
Active
🇺🇸 United States
ARCH - Quakertown
Reg #: 2531477
·
FEI: 3001642380
·
Expires 2025
Products
6
Proprietary Names
0
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- ARCH - Quakertown
- Registration Number
- 2531477
- FEI Number
- 3001642380
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 140 PENN AM DR.
- City
- QUAKERTOWN
- State
- PA
- ZIP
- 18951
- Country
- US
Regulatory Submissions
- 510(k) Number
- K113395
Owner / Operator
- Firm Name
- ARCH - Quakertown
- Operator Number
- 9033309
- Address
- 140 PENN AM DR., --
- City
- Quakertown
- State
- PA
- Postal Code
- 18951
- Country
- US
- Correspondent
- Jeffrey R Kauffman
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | OSH | Class 2 | Orthopedic | No | 2013-01-31 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2013-01-31 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2013-01-31 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2013-01-31 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2013-01-31 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2013-01-31 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)