Cheonan, KR · 13 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Class II | Orthopedic | 7 | 2025-04-17 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Class II | Orthopedic | 4 | 2023-02-27 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Class II | Orthopedic | 1 | 2023-03-16 |
| NKB | Thoracolumbosacral Pedicle Screw System | Class II | Orthopedic | 1 | 2020-03-06 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2025-04-17 | K250889 | EXULT Knee Replacement System | JWH | Class II | Orthopedic |
| 2024-09-12 | K242401 | EXULT Knee Replacement System | JWH | Class II | Orthopedic |
| 2024-08-01 | K242046 | EXULT Knee Replacement System | JWH | Class II | Orthopedic |
| 2023-03-16 | K223828 | BENCOX Delta Option Heads | LZO | Class II | Orthopedic |
| 2023-02-27 | K223223 | BENCOX Mirabo Z Cup Cortinium | LPH | Class II | Orthopedic |
| 2022-08-26 | K222278 | LOSPA TKR System Instrumentation, EXULT TKR System Instrumentation | JWH | Class II | Orthopedic |
| 2022-05-24 | K210614 | BENCOX Mirabo Z Cup Cortinium | LPH | Class II | Orthopedic |
| 2022-05-18 | K220468 | BENCOX Mirabo Cup System | LPH | Class II | Orthopedic |
| 2021-12-09 | K212034 | LOSPA TKR System | JWH | Class II | Orthopedic |
| 2021-07-14 | K211866 | Bencox THR System | LPH | Class II | Orthopedic |
| 2020-07-30 | K201851 | EXULT Femoral component trial - Left, EXULT Femoral component trial - Right | JWH | Class II | Orthopedic |
| 2020-05-07 | K200395 | LOSPA II Knee System (EXULT Knee Replacement System) | JWH | Class II | Orthopedic |
| 2020-03-06 | K200267 | LOSPA® IS Spinal Fixation System | NKB | Class II | Orthopedic |