FDA Registration
Active
🇺🇸 United States
EXPEDIUM
Reg #: 3004464325
·
FEI: 3004464325
·
Expires 2025
Products
6
Proprietary Names
1
Establishment Types
2
Classifications
6
Registration Details
- Registration Name
- DEPUY ORTHOPAEDICS
- Registration Number
- 3004464325
- FEI Number
- 3004464325
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 50 SCOTLAND BLVD.
- City
- BRIDGEWATER
- State
- MA
- ZIP
- 02324
- Country
- US
Regulatory Submissions
- 510(k) Number
- K160904
Owner / Operator
- Firm Name
- DePuy Synthes, Inc.
- Operator Number
- 1818910
- Address
- 700 Orthopaedic Drive
- City
- Warsaw
- State
- IN
- Postal Code
- 46582
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2019-01-08 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2019-01-08 |
| Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | OSH | Class 2 | Orthopedic | No | 2019-01-08 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2019-01-08 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2019-01-08 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2019-01-08 |
Proprietary Names
EXPEDIUM
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device