Summa Orthopaedics Small Fragment System Bone Plate

GUDID 08800089449613

Jeil Medical Corporation

Orthopaedic fixation plate, non-bioabsorbable

• Primary Device ID: 08800089449613
• NIH Device Record Key: 37523600-2c9b-4cbc-8400-ff8d883caf40
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Summa Orthopaedics Small Fragment System Bone Plate
• Version Model Number: SO-25-SFTS-010
• 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	08800089449613 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221920

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

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

[08800089449613]

Moist Heat or Steam Sterilization

[08800089449613]

Moist Heat or Steam Sterilization

[08800089449613]

Moist Heat or Steam Sterilization

[08800089449613]

Moist Heat or Steam Sterilization

[08800089449613]

Moist Heat or Steam Sterilization

[08800089449613]

Moist Heat or Steam Sterilization

[08800089449613]

Moist Heat or Steam Sterilization

[08800089449613]

Moist Heat or Steam Sterilization

[08800089449613]

Moist Heat or Steam Sterilization

[08800089449613]

Moist Heat or Steam Sterilization

[08800089449613]

Moist Heat or Steam Sterilization

[08800089449613]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-10-03
• Device Publish Date: 2024-09-25

On-Brand Devices [Summa Orthopaedics Small Fragment System Bone Plate]

• 08800089449637: SO-25-SFTS-112
• 08800089449620: SO-25-SFTS-108
• 08800089449613: SO-25-SFTS-010
• 08800089449606: SO-25-SFTS-008
• 08800089449590: SO-25-SFTR-014
• 08800089449583: SO-25-SFTR-012
• 08800089449576: SO-25-SFST-020
• 08800089449569: SO-25-SFST-010
• 08800089449552: SO-25-SFST-008
• 08800089449545: SO-25-SFST-006
• 08800089449538: SO-25-SFST-004