Tampa, FL, US · 8 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Class II | Orthopedic | 2 | 2024-09-23 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Class II | Orthopedic | 2 | 2022-04-07 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Class II | Orthopedic | 1 | 2025-06-05 |
| LLZ | System, Image Processing, Radiological | Class II | Radiology | 1 | 2025-01-07 |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | Class II | Orthopedic | 1 | 2024-10-03 |
| OLO | Orthopedic Stereotaxic Instrument | Class II | Neurology | 1 | 2023-07-26 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2025-06-05 | K242744 | Trinity EVO Acetabular Shell | LPH | Class II | Orthopedic |
| 2025-01-07 | K241808 | ApolloHipX (THR.SS.0001) | LLZ | Class II | Radiology |
| 2024-10-03 | K241472 | Icona Hip Stem | MEH | Class II | Orthopedic |
| 2024-09-23 | K241570 | Unity Total Knee System | JWH | Class II | Orthopedic |
| 2024-06-26 | K240875 | Unity Knee PS-C Tibial Insert | JWH | Class II | Orthopedic |
| 2023-07-26 | K231172 | ApolloKnee | OLO | Class II | Neurology |
| 2022-04-07 | K212069 | Corin MetaFix Hip Stem | LZO | Class II | Orthopedic |
| 2020-01-16 | K191831 | MobiliT Cup | LZO | Class II | Orthopedic |