FDA Registration
Active
🇺🇸 United States
MOD BRKT TIB BROACH J/9-10
Reg #: 1832228
·
FEI: 1832228
·
Expires 2025
Products
3
Proprietary Names
17
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- Viant AS&O Holdings, LLC
- Registration Number
- 1832228
- FEI Number
- 1832228
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 3735 NORTH ARLINGTON AVE.
- City
- Indianapolis
- State
- IN
- ZIP
- 46218
- Country
- US
Regulatory Submissions
- 510(k) Number
- K221479
Owner / Operator
- Firm Name
- Viant Medical, LLC
- Operator Number
- 9043339
- Address
- 2 Hampshire Street, Suite 202
- City
- Foxborough
- State
- MA
- Postal Code
- 02035
- Country
- US
- Correspondent
- David - Rose
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | MBH | Class 2 | Orthopedic | No | 2024-09-26 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2024-09-26 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | OIY | Class 2 | Orthopedic | No | 2024-09-26 |
Proprietary Names
MOD BRKT TIB BROACH J/9-10
MOD BRKT C-D SIZING PLATE
MOD BRKT G-H SIZING PLATE
MOD BRKT TIBIAL DRILL GUIDE
MOD BRKT TIB CUT GDE
MOD BRKT TIBIAL BROACH INS/EXT
MOD BRKT TIB BROACH E-F/5-6
MOD BRKT TIB BROACH G-H/7-8
MOD BRKT DRILL
Persona Knee System
MOD BRKT TIB IMPACTOR PAD
MOD BRKT E-F SIZING PLATE
MOD BRKT PEG DRILL
MOD BRKT TIB BROACH A-B/1-2
MOD BRKT TIB BROACH C-D/3-4
MOD BRKT A-B SIZING PLATE
MOD BRKT TIB ALIGN GDE
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)