FDA Registration
Active
🇺🇸 United States
Response BandLoc Spinal Fixation
Reg #: 3006460162
·
FEI: 3006460162
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
3
Classifications
1
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
- K161267
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 |
|---|---|---|---|---|---|
| Bone Fixation Cerclage, Sublaminar | OWI | Class 2 | Orthopedic | No | 2016-08-12 |
Proprietary Names
Response BandLoc Spinal Fixation
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility