FDA Registration
Active
🇺🇸 United States
SYNTHES PANGEA SYSTEM
Reg #: 3008812560
·
FEI: 3008812560
·
Expires 2025
Products
5
Proprietary Names
1
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- Synthes (USA) Products LLC
- Registration Number
- 3008812560
- FEI Number
- 3008812560
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 1301 Goshen Pkwy
- City
- West Chester
- State
- PA
- ZIP
- 19380
- Country
- US
Regulatory Submissions
- 510(k) Number
- K052123
Owner / Operator
- Firm Name
- SYNTHES (USA) Products LLC / Medical Device Business Service
- Operator Number
- 2520274
- Address
- 1301 Goshen Parkway, --
- City
- West Chester
- State
- PA
- Postal Code
- 19380
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2007-12-21 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2007-12-21 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2007-12-21 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2007-12-21 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2007-12-21 |
Proprietary Names
SYNTHES PANGEA SYSTEM
Establishment Types
Complaint File Establishment per 21 CFR 820.198