FDA Registration
Active
🇺🇸 United States
PULSE TECHNOLOGIES, INC.
Reg #: 2532027
·
FEI: 3003292403
·
Expires 2026
Products
19
Proprietary Names
1
Establishment Types
1
Classifications
19
Registration Details
- Registration Name
- PULSE TECHNOLOGIES, INC.
- Registration Number
- 2532027
- FEI Number
- 3003292403
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 2000 AM DRIVE
- City
- QUAKERTOWN
- State
- PA
- ZIP
- 18951
- Country
- US
Owner / Operator
- Firm Name
- PULSE TECHNOLOGIES, INC.
- Operator Number
- 9044299
- Address
- 2000 AM DRIVE, --
- City
- Quakertown
- State
- PA
- Postal Code
- 18951
- Country
- US
- Correspondent
- Mark MANGINI
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stimulator, Nerve | ETN | Class 2 | Ear, Nose, Throat | No | 2016-11-29 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2013-03-20 |
| Spinal Vertebral Body Replacement Device | MQP | Class 2 | Orthopedic | No | 2016-11-29 |
| Intervertebral Fusion Device With Bone Graft, Thoracic | PHM | Class 2 | Orthopedic | No | 2016-11-29 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2016-11-29 |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | Class 2 | Orthopedic | No | 2018-10-25 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2016-11-29 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2016-11-29 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2016-11-29 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2016-11-29 |
| Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | OSH | Class 2 | Orthopedic | No | 2016-11-29 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2013-03-20 |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2016-11-29 |
| Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | HSX | Class 2 | Orthopedic | No | 2025-01-24 |
| Washer, Bolt Nut | HTN | Class 2 | Orthopedic | No | 2020-03-05 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2020-03-05 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2018-10-25 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | Class 2 | Orthopedic | No | 2025-12-03 |
| Spinal Vertebral Body Replacement Device - Cervical | PLR | Class 2 | Orthopedic | No | 2020-10-23 |
Proprietary Names
Arcadius
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)