Summa Orthopaedics Ankle System Bone Plate

GUDID 08800089451234

Jeil Medical Corporation

Orthopaedic fixation plate, non-bioabsorbable

• Primary Device ID: 08800089451234
• NIH Device Record Key: 1cdf8dc4-1af7-497e-8d9f-f4e5cf79260e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Summa Orthopaedics Ankle System Bone Plate
• Version Model Number: SO-35V-DLF3-007-R
• 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	08800089451234 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231441

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

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

[08800089451234]

Moist Heat or Steam Sterilization

[08800089451234]

Moist Heat or Steam Sterilization

[08800089451234]

Moist Heat or Steam Sterilization

[08800089451234]

Moist Heat or Steam Sterilization

[08800089451234]

Moist Heat or Steam Sterilization

[08800089451234]

Moist Heat or Steam Sterilization

[08800089451234]

Moist Heat or Steam Sterilization

[08800089451234]

Moist Heat or Steam Sterilization

[08800089451234]

Moist Heat or Steam Sterilization

[08800089451234]

Moist Heat or Steam Sterilization

[08800089451234]

Moist Heat or Steam Sterilization

[08800089451234]

Moist Heat or Steam Sterilization

[08800089451234]

Moist Heat or Steam Sterilization

[08800089451234]

Moist Heat or Steam Sterilization

[08800089451234]

Moist Heat or Steam Sterilization

[08800089451234]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-10-04
• Device Publish Date: 2024-09-26

On-Brand Devices [Summa Orthopaedics Ankle System Bone Plate]

• 08806390863216: SO-35-DLST-010
• 08806390863209: SO-35-DLST-008
• 08806390863193: SO-35-DLST-006
• 08806390863186: SO-35-DLST-005
• 08806390863179: SO-35-DLST-004
• 08806390863162: SO-35-DLST-003
• 08806390863155: SO-35-DLFI-008-R
• 08806390863148: SO-35-DLFI-008-L
• 08806390863131: SO-35-DLFI-007-R
• 08806390863124: SO-35-DLFI-007-L
• 08806390863117: SO-35-DLFI-006-R
• 08806390863100: SO-35-DLFI-006-L
• 08806390863094: SO-35-DLFI-005-R
• 08806390863087: SO-35-DLFI-005-L
• 08806390863070: SO-35-DLFI-004-R
• 08806390863063: SO-35-DLFI-004-L
• 08806390863056: SO-35-DLFI-003-R
• 08806390863049: SO-35-DLFI-003-L
• 08800089451302: SO-35V-DLF3-008-L
• 08800089451296: SO-35V-DLF3-007-L
• 08800089451289: SO-35V-DLF3-006-L
• 08800089451272: SO-35V-DLF3-005-L
• 08800089451265: SO-35V-DLF3-004-L
• 08800089451258: SO-35V-DLF3-003-L
• 08800089451241: SO-35V-DLF3-008-R
• 08800089451234: SO-35V-DLF3-007-R
• 08800089451227: SO-35V-DLF3-006-R
• 08800089451210: SO-35V-DLF3-005-R
• 08800089451203: SO-35V-DLF3-004-R
• 08800089451197: SO-35V-DLF3-003-R