FDA device listing
MOD BRKT A-B SIZING PLATE,MOD BRKT C-D SIZING PLATE,MOD BRKT DRILL,MOD BRKT E-F SIZING PLATE,MOD BRKT G-H SIZING…
FDA device listing 1024648434 · Viant Medical, LLC
Key facts
| Proprietary names | MOD BRKT A-B SIZING PLATE,MOD BRKT C-D SIZING PLATE,MOD BRKT DRILL,MOD BRKT E-F SIZING PLATE,MOD BRKT G-H SIZING PLATE,MOD BRKT PEG DRILL,MOD BRKT TIB ALIGN GDE,MOD BRKT TIB BROACH A-B/1-2,MOD BRKT TIB BROACH C-D/3-4,MOD BRKT TIB BROACH E-F/5-6,MOD BRKT TIB BROACH G-H/7-8,MOD BRKT TIB BROACH J/9-10,MOD BRKT TIB CUT GDE,MOD BRKT TIBIAL BROACH INS/EXT,MOD BRKT TIBIAL DRILL GUIDE,MOD BRKT TIB… |
|---|---|
| Owner/operator | Viant Medical, LLC |
| Owner/operator number | 9043339 |
| Product codes | JWH, MBH, OIY |
| Device names | JWH - Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, MBH - Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer, OIY - Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive |
| Device class | Class II |
| Classification regulations (21 CFR) | 888.3560, 888.3565 |
| Review panels | Orthopedic |
| Registered establishments | Viant AS&O Holdings, LLC |
| Establishment registrations | 1832228 |
| FEI numbers | 1832228 |
| Establishment operations | Contract Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database