Summa Orthopaedics Foot System Bone Plate

GUDID 08806390865937

Jeil Medical Corporation

Orthopaedic fixation plate, non-bioabsorbable

• Primary Device ID: 08806390865937
• NIH Device Record Key: e7541223-96e0-4b51-90f4-fe04f560ea63
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Summa Orthopaedics Foot System Bone Plate
• Version Model Number: SO-35L-CLCC-113-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	08806390865937 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161864

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

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

[08806390865937]

Moist Heat or Steam Sterilization

[08806390865937]

Moist Heat or Steam Sterilization

[08806390865937]

Moist Heat or Steam Sterilization

[08806390865937]

Moist Heat or Steam Sterilization

[08806390865937]

Moist Heat or Steam Sterilization

[08806390865937]

Moist Heat or Steam Sterilization

[08806390865937]

Moist Heat or Steam Sterilization

[08806390865937]

Moist Heat or Steam Sterilization

[08806390865937]

Moist Heat or Steam Sterilization

[08806390865937]

Moist Heat or Steam Sterilization

[08806390865937]

Moist Heat or Steam Sterilization

[08806390865937]

Moist Heat or Steam Sterilization

[08806390865937]

Moist Heat or Steam Sterilization

[08806390865937]

Moist Heat or Steam Sterilization

[08806390865937]

Moist Heat or Steam Sterilization

[08806390865937]

Moist Heat or Steam Sterilization

[08806390865937]

Moist Heat or Steam Sterilization

[08806390865937]

Moist Heat or Steam Sterilization

[08806390865937]

Moist Heat or Steam Sterilization

[08806390865937]

Moist Heat or Steam Sterilization

[08806390865937]

Moist Heat or Steam Sterilization

[08806390865937]

Moist Heat or Steam Sterilization

[08806390865937]

Moist Heat or Steam Sterilization

[08806390865937]

Moist Heat or Steam Sterilization

[08806390865937]

Moist Heat or Steam Sterilization

[08806390865937]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2024-06-07
• Device Publish Date: 2018-05-02

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

• 08806390866033: SO-35M-CLCC-306-R
• 08806390866026: SO-35M-CLCC-206-R
• 08806390866019: SO-35M-CLCC-106-R
• 08806390866002: SO-35M-CLCC-005-R
• 08806390865999: SO-35M-CLCC-306-L
• 08806390865982: SO-35M-CLCC-206-L
• 08806390865975: SO-35M-CLCC-106-L
• 08806390865968: SO-35M-CLCC-005-L
• 08806390865951: SO-35L-CLCC-313-R
• 08806390865944: SO-35L-CLCC-213-R
• 08806390865937: SO-35L-CLCC-113-R
• 08806390865920: SO-35L-CLCC-012-R
• 08806390865913: SO-35L-CLCC-313-L
• 08806390865906: SO-35L-CLCC-213-L
• 08806390865890: SO-35L-CLCC-113-L
• 08806390865883: SO-35L-CLCC-012-L