FDA device listing
Arthrex iBalance Bicompartmental Arthroplasty System,Arthrex iBalance PFJ,Arthrex iBalance TKA System,Arthrex iBalance…
FDA device listing 1314346207 · Orthoplastics Ltd
Key facts
| Proprietary names | Arthrex iBalance Bicompartmental Arthroplasty System,Arthrex iBalance PFJ,Arthrex iBalance TKA System,Arthrex iBalance UKA System |
|---|---|
| Owner/operator | Orthoplastics Ltd |
| Owner/operator number | 10054760 |
| Product codes | HSX, KRR, MBH |
| Device names | HSX - Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer, KRR - Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer, MBH - Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer |
| Device class | Class II |
| Classification regulations (21 CFR) | 888.3520, 888.3540, 888.3565 |
| Review panels | Orthopedic |
| Registered establishments | ORTHOPLASTICS LTD |
| Establishment registrations | 3000264985 |
| FEI numbers | 3000264985 |
| 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