FDA Registration
Active
🇺🇸 United States
Response 5.5/6 Spine System
Reg #: 3006460162
·
FEI: 3006460162
·
Expires 2025
Products
5
Proprietary Names
2
Establishment Types
3
Classifications
5
Registration Details
- Registration Name
- ORTHOPEDIATRICS, CORP
- Registration Number
- 3006460162
- FEI Number
- 3006460162
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 2850 Frontier Dr
- City
- Warsaw
- State
- IN
- ZIP
- 46582
- Country
- US
Regulatory Submissions
- 510(k) Number
- K150600
Owner / Operator
- Firm Name
- ORTHOPEDIATRICS, CORP
- Operator Number
- 9102640
- Address
- 2850 Frontier Drive, --
- City
- Warsaw
- State
- IN
- Postal Code
- 46582
- Country
- US
- Correspondent
- Ray Garrison
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | OSH | Class 2 | Orthopedic | No | 2015-05-26 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2015-05-26 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2015-05-26 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2015-05-26 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2015-05-26 |
Proprietary Names
Response 5.5/6 Spine System
Aspire Ortho Spine System
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility