Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K132876
ARIX HAND LOCKING SYSTEM · Jeil Medical Corporation · decided 2013-12-18 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| INLET System Bone Screw | IN20L-HF-008 | Jeil Medical Corporation | HWC | 08800089411894 |
| ARIX Hand System Bone Plate | H2L-QD-006 | Jeil Medical Corporation | HRS | 08809282816536 |
| ARIX Hand System Bone Plate | H2L-LR-006 | Jeil Medical Corporation | HRS | 08806390825375 |
| ARIX Hand System Bone Plate | H2L-ST-004 | Jeil Medical Corporation | HRS | 08809282816451 |
| ARIX Hand System Bone Plate | H2L-ST-006 | Jeil Medical Corporation | HRS | 08806390827676 |
| INLET New Hand System Bone Plate | INH2L-YP-007 | Jeil Medical Corporation | HRS | 08800089412273 |
| ARIX Hand System Bone Plate | H2L-QD-008 | Jeil Medical Corporation | HRS | 08809282816543 |
| ARIX Hand System Bone Plate | H2L-LR-006 | Jeil Medical Corporation | HRS | 08809282816505 |
| ARIX System Bone Screw | 20-HF-026 | Jeil Medical Corporation | HWC | 08809282816420 |
| ARIX System Bone Screw | 20L-HF-020 | Jeil Medical Corporation | HWC | 08809282816390 |
| ARIX System Bone Screw | 20-HF-018 | Jeil Medical Corporation | HWC | 08809282816703 |
| INLET System Bone Screw | IN20L-HF-013 | Jeil Medical Corporation | HWC | 08800089411849 |
| ARIX System Bone Screw | 20-HF-021 | Jeil Medical Corporation | HWC | 08809282816734 |
| ARIX System Bone Screw | 20-HF-016 | Jeil Medical Corporation | HWC | 08809282816697 |
| ARIX System Bone Screw | 20-HF-028 | Jeil Medical Corporation | HWC | 08809282816437 |
| INLET System Bone Screw | IN20L-HF-020 | Jeil Medical Corporation | HWC | 08800089411801 |
| ARIX System Bone Screw | 20L-HF-013 | Jeil Medical Corporation | HWC | 08809282816352 |
| ARIX System Bone Screw | 20L-HF-009 | Jeil Medical Corporation | HWC | 08809282816314 |
| ARIX Hand System Bone Plate | H2L-QD-008 | Jeil Medical Corporation | HRS | 08806390828864 |
| INLET New Hand System Bone Plate | INH2L-LR-006 | Jeil Medical Corporation | HRS | 08800089412297 |
| INLET System Bone Screw | IN20-HF-011 | Jeil Medical Corporation | HWC | 08800089411986 |
| ARIX Hand System Bone Plate | H2L-ST-006 | Jeil Medical Corporation | HRS | 08806390828819 |
| ARIX System Bone Screw | 20L-HF-012 | Jeil Medical Corporation | HWC | 08809282816345 |
| ARIX Hand System Bone Plate | H2L-ST-006 | Jeil Medical Corporation | HRS | 08809282816468 |
| INLET System Bone Screw | IN20-HF-008 | Jeil Medical Corporation | HWC | 08800089412013 |