FDA Registration
Active
🇺🇸 United States
Ultima HA Coated Half Pins and Wire
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
- K163487
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 |
|---|---|---|---|---|---|
| Pin, Fixation, Threaded | JDW | Class 2 | Orthopedic | No | 2019-12-13 |
Proprietary Names
Ultima HA Coated Half Pins and Wire
Establishment Types
Repack or Relabel Medical Device
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility