Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K202912
ARIX Ankle Distal Tibia System · Jeil Medical Corporation · decided 2020-10-29 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| INLET System Bone Screw | IN40-SA-018-T | Jeil Medical Corporation | HWC | 08800089416080 |
| Summa Orthopaedics System Bone Screw | SO-35-SO-L55-T | Jeil Medical Corporation | HWC | 08800089435906 |
| INLET System Surgical Instrument | IN112-136 | Jeil Medical Corporation | KCT | 08800089415182 |
| Summa Orthopaedics Ankle Distal Tibia System Bone Plate | SO-35-DLTB-003-L | Jeil Medical Corporation | HRS | 08800089408719 |
| INLET System Bone Screw | IN40-SA-036-T | Jeil Medical Corporation | HWC | 08800089415991 |
| INLET System Bone Screw | IN40-SA-014-T | Jeil Medical Corporation | HWC | 08800089416103 |
| ARIX System Bone Screw | 40-SA-030-T | Jeil Medical Corporation | HWC | 08800089409594 |
| ARIX Ankle Distal Tibia System Bone Plate | 35-DMTB-004-R | Jeil Medical Corporation | HRS | 08806390883412 |
| INLET System Bone Screw | IN35-SO-L24-T | Jeil Medical Corporation | HWC | 08800089418091 |
| INLET System Bone Screw | IN35-SO-L34-T | Jeil Medical Corporation | HWC | 08800089418046 |
| INLET Distal Tibia System Bone Plate | IN35-DMTB-004-L | Jeil Medical Corporation | HRS | 08800089415434 |
| Summa Orthopaedics System Bone Screw | SO-40L-SA-010-TA | Jeil Medical Corporation | HWC | 08800089409167 |
| ARIX System Bone Screw | 40-SA-036-T | Jeil Medical Corporation | HWC | 08800089409624 |
| ARIX System Bone Screw | 35-SO-L42-T | Jeil Medical Corporation | HWC | 08806390848718 |
| ARIX System Bone Screw | 35-SO-L14-T | Jeil Medical Corporation | HWC | 08806390848572 |
| INLET System Bone Screw | IN35L-SO-L44-TA | Jeil Medical Corporation | HWC | 08800089415564 |
| Summa Orthopaedics System Bone Screw | SO-40-SA-042-T | Jeil Medical Corporation | HWC | 08800089409099 |
| Summa Orthopaedics Ankle Distal Tibia System Bone Plate | SO-35-DMTB-006-R | Jeil Medical Corporation | HRS | 08800089408849 |
| ARIX System Bone Screw | 40L-SA-016-TA | Jeil Medical Corporation | HWC | 08800089407873 |
| Summa Orthopaedics System Bone Screw | SO-35L-SO-L10-TA | Jeil Medical Corporation | HWC | 08806390866989 |
| INLET System Bone Screw | IN35-SO-L56-T | Jeil Medical Corporation | HWC | 08800089415649 |
| INLET System Bone Screw | IN35-SO-L14-T | Jeil Medical Corporation | HWC | 08800089418145 |
| ARIX System Bone Screw | 40-SA-046-T | Jeil Medical Corporation | HWC | 08800089409679 |
| INLET System Bone Screw | IN40L-SA-010-TA | Jeil Medical Corporation | HWC | 08800089415892 |
| Summa Orthopaedics Ankle Distal Tibia System Bone Plate | SO-35-DLTB-008-L | Jeil Medical Corporation | HRS | 08800089408771 |