FDA Registration
Active
🇺🇸 United States
iTotal G2 Tibial insert
Reg #: 1646498
·
FEI: 1000138247
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- Micron Solutions, Inc.
- Registration Number
- 1646498
- FEI Number
- 1000138247
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 25 SAWYER PASSWAY
- City
- FITCHBURG
- State
- MA
- ZIP
- 01420
- Country
- US
Regulatory Submissions
- 510(k) Number
- K131467
Owner / Operator
- Firm Name
- Micron Solutions, Inc.
- Operator Number
- 9009513
- Address
- 25 SAWYER PASSWAY
- City
- Fitchburg
- State
- MA
- Postal Code
- 01420
- Country
- US
- Correspondent
- Geraldine L St Jean
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2014-07-25 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | OIY | Class 2 | Orthopedic | No | 2014-07-25 |
| Knee Arthroplasty Implantation System | OOG | Class 2 | Orthopedic | No | 2014-07-25 |
Proprietary Names
iTotal G2 Tibial insert
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)