ARIX Foot System Bone Plate

GUDID 08809282815119

Jeil Medical Corporation

Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable

• Primary Device ID: 08809282815119
• NIH Device Record Key: 0f95acb7-7d72-4ac9-9200-27ae73d85a3c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ARIX Foot System Bone Plate
• Version Model Number: F35-CL-112-16
• Company DUNS: 688811603
• Company Name: Jeil Medical Corporation
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809282815119 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131311

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[08809282815119]

Moist Heat or Steam Sterilization

[08809282815119]

Moist Heat or Steam Sterilization

[08809282815119]

Moist Heat or Steam Sterilization

[08809282815119]

Moist Heat or Steam Sterilization

[08809282815119]

Moist Heat or Steam Sterilization

[08809282815119]

Moist Heat or Steam Sterilization

[08809282815119]

Moist Heat or Steam Sterilization

[08809282815119]

Moist Heat or Steam Sterilization

[08809282815119]

Moist Heat or Steam Sterilization

[08809282815119]

Moist Heat or Steam Sterilization

[08809282815119]

Moist Heat or Steam Sterilization

[08809282815119]

Moist Heat or Steam Sterilization

[08809282815119]

Moist Heat or Steam Sterilization

[08809282815119]

Moist Heat or Steam Sterilization

[08809282815119]

Moist Heat or Steam Sterilization

[08809282815119]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 7
• Public Version Date: 2024-06-12
• Device Publish Date: 2015-09-24

On-Brand Devices [ARIX Foot System Bone Plate]

• 08806390849203: 35D-CLCC-304-R
• 08806390849197: 35D-CLCC-204-R
• 08806390849180: 35D-CLCC-104-R
• 08806390849173: 35D-CLCC-004-R
• 08806390849166: 35D-CLCC-304-L
• 08806390849159: 35D-CLCC-204-L
• 08806390849142: 35D-CLCC-104-L
• 08806390849135: 35D-CLCC-004-L
• 08806390849128: 35M-CLCC-306-R
• 08806390849111: 35M-CLCC-206-R
• 08806390849104: 35M-CLCC-106-R
• 08806390849098: 35M-CLCC-005-R
• 08806390849081: 35M-CLCC-306-L
• 08806390849074: 35M-CLCC-206-L
• 08806390849067: 35M-CLCC-106-L
• 08806390849050: 35M-CLCC-005-L
• 08806390849043: 35L-CLCC-313-R
• 08806390849036: 35L-CLCC-213-R
• 08806390849029: 35L-CLCC-113-R
• 08806390849012: 35L-CLCC-012-R
• 08806390849005: 35L-CLCC-313-L
• 08806390848992: 35L-CLCC-213-L
• 08806390848985: 35L-CLCC-113-L
• 08806390848978: 35L-CLCC-012-L
• 08806390854146: F23-QR-008-13
• 08806390854054: F28-TR-005-16
• 08806390854047: F28-TR-004-16
• 08806390854030: F28-TL-005-16
• 08806390854023: F28-TL-004-16
• 08806390854016: F28-XR-204-16
• 08806390854009: F28-XR-104-16
• 08806390853996: F28-XR-004-16
• 08806390853989: F28-XL-204-16
• 08806390853972: F28-XL-104-16
• 08806390853965: F28-XL-004-16
• 08806390853958: F28-LR-305-16
• 08806390853941: F28-LR-304-16
• 08806390853934: F28-LR-205-16
• 08806390853927: F28-LR-204-16
• 08806390853910: F28-LR-105-16
• 08806390853903: F28-LR-104-16
• 08806390853897: F28-LR-005-16
• 08806390853880: F28-LR-004-16
• 08806390853873: F28-LL-305-16
• 08806390853866: F28-LL-304-16
• 08806390853859: F28-LL-205-16
• 08806390853842: F28-LL-204-16
• 08806390853835: F28-LL-105-16
• 08806390853828: F28-LL-104-16
• 08806390853811: F28-LL-005-16