Summa Orthopaedics Femur Nail System

GUDID 08800089461615

Jeil Medical Corporation

Orthopaedic bone screw (non-sliding)

• Primary Device ID: 08800089461615
• NIH Device Record Key: 52273d32-38fc-4e6d-8bd2-9a0822d78967
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Summa Orthopaedics Femur Nail System
• Version Model Number: SO-S50I-SO-027-T
• 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: true
• 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	08800089461615 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242247

FDA Product Code

• HSB: Rod, Fixation, Intramedullary And Accessories

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-06-06
• Device Publish Date: 2025-05-29

On-Brand Devices [Summa Orthopaedics Femur Nail System]

• 08800089465309: SO-50I-SO-048-T
• 08800089465293: SO-50I-SO-047-T
• 08800089465286: SO-50I-SO-046-T
• 08800089465279: SO-50I-SO-045-T
• 08800089465262: SO-50I-SO-044-T
• 08800089465255: SO-50I-SO-043-T
• 08800089465248: SO-50I-SO-042-T
• 08800089465231: SO-50I-SO-041-T
• 08800089465224: SO-50I-SO-040-T
• 08800089465217: SO-50I-SO-039-T
• 08800089465200: SO-50I-SO-038-T
• 08800089465194: SO-50I-SO-037-T
• 08800089465187: SO-50I-SO-036-T
• 08800089465170: SO-50I-SO-035-T
• 08800089465163: SO-50I-SO-034-T
• 08800089465156: SO-50I-SO-033-T
• 08800089465149: SO-50I-SO-032-T
• 08800089465132: SO-50I-SO-031-T
• 08800089465125: SO-50I-SO-030-T
• 08800089465118: SO-50I-SO-029-T
• 08800089465101: SO-50I-SO-028-T
• 08800089465095: SO-50I-SO-027-T
• 08800089465088: SO-50I-SO-026-T
• 08800089465071: SO-50I-SO-025-T
• 08800089465064: SO-50I-SO-024-T
• 08800089465057: SO-50I-SO-023-T
• 08800089465040: SO-50I-SO-022-T
• 08800089465033: SO-50I-SO-021-T
• 08800089465026: SO-50I-SO-020-T
• 08800089465019: SO-50I-SO-019-T
• 08800089465002: SO-50I-SO-018-T
• 08800089464999: SO-50I-SO-017-T
• 08800089464982: SO-50I-SO-016-T
• 08800089464975: SO-PFL-N130
• 08800089464968: SO-PFL-N125
• 08800089464951: SO-PFL-N120
• 08800089464944: SO-PFL-N115
• 08800089464937: SO-PFL-N110
• 08800089464920: SO-PFL-N105
• 08800089464913: SO-PFL-N100
• 08800089464906: SO-PFL-N095
• 08800089464890: SO-PFL-N090
• 08800089464883: SO-PFL-N085
• 08800089464876: SO-PFL-N080
• 08800089464869: SO-PFL-N075
• 08800089464852: SO-PFL-N070
• 08800089464845: SO-PFN-0440-13L-30
• 08800089464838: SO-PFN-0420-13L-30
• 08800089464821: SO-PFN-0400-13L-30
• 08800089464814: SO-PFN-0280-13L-30