ARIX Foot System
by Jeil Medical Corporation 2 variants
510(k) K161864
ARIX Foot System is a Class II device made by Jeil Medical Corporation, cleared under FDA 510(k) K161864 on 2 Aug 2016, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK161864 | Date2 Aug 2016 | StatusActive |
Official records
- FDA 510(k) database K161864
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- HRS
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3030
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K161864
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| ARIX Foot System Bone Plate 35M-CLCC-005-L | 35M-CLCC-005-L | 08806390849050 | — | On the market |
| ARIX Foot System Bone Plate 35M-CLCC-206-L | 35M-CLCC-206-L | 08806390849074 | — | On the market |
| ARIX System Bone Screw 28-FC-016 | 28-FC-016 | 08809282813191 | — | On the market |
| ARIX System Bone Screw 28-FC-028 | 28-FC-028 | 08809282813252 | — | On the market |
| ARIX System Bone Screw 28-FC-032 | 28-FC-032 | 08809282815287 | — | On the market |
| ARIX System Bone Screw 28-SO-L12-TA | 28-SO-L12-TA | 08806390886512 | — | On the market |
| ARIX System Bone Screw 28L-HF-008 | 28L-HF-008 | 08809282812835 | — | On the market |
| ARIX System Bone Screw 28L-HF-045 | 28L-HF-045 | 08809282813009 | — | On the market |
| ARIX System Bone Screw 28L-SO-L14-TA | 28L-SO-L14-TA | 08806390884938 | — | On the market |
| ARIX System Bone Screw 28L-SO-L22-TA | 28L-SO-L22-TA | 08806390884976 | — | On the market |
| ARIX System Bone Screw 28L-SO-L36-TA | 28L-SO-L36-TA | 08800089436415 | — | On the market |
| ARIX System Bone Screw 35-FC-010 | 35-FC-010 | 08809282815294 | — | On the market |
| ARIX System Bone Screw 35-FC-018 | 35-FC-018 | 08809282813351 | — | On the market |
| ARIX System Bone Screw 35-FC-028 | 35-FC-028 | 08809282813399 | — | On the market |
| ARIX System Bone Screw 35-SO-L12-T | 35-SO-L12-T | 08806390848565 | — | On the market |
| ARIX System Bone Screw 35-SO-L18-T | 35-SO-L18-T | 08806390848596 | — | On the market |
| ARIX System Bone Screw 35-SO-L26-T | 35-SO-L26-T | 08806390848633 | — | On the market |
| ARIX System Bone Screw 35-SO-L30-T | 35-SO-L30-T | 08806390848657 | — | On the market |
| ARIX System Bone Screw 35L-HF-018 | 35L-HF-018 | 08809282813054 | — | On the market |
| ARIX System Bone Screw 35L-SO-L10-TA | 35L-SO-L10-TA | 08806390848763 | — | On the market |
| ARIX System Bone Screw 35L-SO-L12-TA | 35L-SO-L12-TA | 08806390848770 | — | On the market |
| ARIX System Bone Screw 35L-SO-L18-TA | 35L-SO-L18-TA | 08806390848800 | — | On the market |
| INLET System Bone Screw IN35-SO-L12-T | IN35-SO-L12-T | 08800089418152 | — | On the market |
| INLET System Bone Screw IN35-SO-L38-T | IN35-SO-L38-T | 08800089415632 | — | On the market |
| INLET System Bone Screw IN35-SO-L45-T | IN35-SO-L45-T | 08800089417124 | — | On the market |
| INLET System Bone Screw IN35L-SO-L10-TA | IN35L-SO-L10-TA | 08800089417933 | — | On the market |
| INLET System Bone Screw IN35L-SO-L26-TA | IN35L-SO-L26-TA | 08800089417858 | — | On the market |
| INLET System Bone Screw IN35L-SO-L40-TA | IN35L-SO-L40-TA | 08800089417094 | — | On the market |
| INLET System Bone Screw IN35L-SO-L42-TA | IN35L-SO-L42-TA | 08800089415571 | — | On the market |
| INLET System Bone Screw IN35L-SO-L44-TA | IN35L-SO-L44-TA | 08800089415564 | — | On the market |
| Summa Orthopaedics Foot System Bone Plate SO-35L-CLCC-012-R | SO-35L-CLCC-012-R | 08806390865920 | — | On the market |
| Summa Orthopaedics Foot System Bone Plate SO-35L-CLCC-313-R | SO-35L-CLCC-313-R | 08806390865951 | — | On the market |
| Summa Orthopaedics Foot System Bone Plate SO-35M-CLCC-206-L | SO-35M-CLCC-206-L | 08806390865982 | — | On the market |
| Summa Orthopaedics System Bone Screw SO-28L-SO-L12-TA | SO-28L-SO-L12-TA | 08800089435944 | — | On the market |
| Summa Orthopaedics System Bone Screw SO-35-SO-L10-T | SO-35-SO-L10-T | 08806390866040 | — | On the market |
| Summa Orthopaedics System Bone Screw SO-35-SO-L14-T | SO-35-SO-L14-T | 08806390866064 | — | On the market |
| Summa Orthopaedics System Bone Screw SO-35-SO-L32-T | SO-35-SO-L32-T | 08806390866156 | — | On the market |
| Summa Orthopaedics System Bone Screw SO-35-SO-L34-T | SO-35-SO-L34-T | 08806390866163 | — | On the market |
| Summa Orthopaedics System Bone Screw SO-35-SO-L40-T | SO-35-SO-L40-T | 08806390866194 | — | On the market |
| Summa Orthopaedics System Bone Screw SO-35L-SO-L16-TA | SO-35L-SO-L16-TA | 08806390867016 | — | On the market |
| Summa Orthopaedics System Bone Screw SO-35L-SO-L20-TA | SO-35L-SO-L20-TA | 08806390867030 | — | On the market |
| VERUM Foot System Bone Plate VC1020 | VC1020 | 08806390871235 | — | On the market |
| VERUM Foot System Bone Plate VC2010 | VC2010 | 08806390871303 | — | On the market |
| VERUM System Bone Screw VC3510-L | VC3510-L | 08806390871013 | — | On the market |
| VERUM System Bone Screw VC3518-L | VC3518-L | 08806390871051 | — | On the market |
| VERUM System Bone Screw VC3520-L | VC3520-L | 08806390871068 | — | On the market |
| VERUM System Bone Screw VC3522 | VC3522 | 08806390870863 | — | On the market |
| VERUM System Bone Screw VC3522-L | VC3522-L | 08806390871075 | — | On the market |
| VERUM System Bone Screw VC3534 | VC3534 | 08806390870924 | — | On the market |
| VERUM System Bone Screw VC3544-L | VC3544-L | 08806390871181 | — | On the market |
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