Summa Orthopaedics Elbow System Bone Plate

GUDID 08800089402618

Jeil Medical Corporation

Orthopaedic fixation plate, non-bioabsorbable, non-sterile

• Primary Device ID: 08800089402618
• NIH Device Record Key: d657af1b-1c76-48e4-bc37-56b1366be280
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Summa Orthopaedics Elbow System Bone Plate
• Version Model Number: SO-35-DPHU-108-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	08800089402618 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201656

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

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

[08800089402618]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-02-19
• Device Publish Date: 2021-05-28

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

• 08800089402618: SO-35-DPHU-108-R
• 08800089402601: SO-35-DPHU-106-R
• 08800089402595: SO-35-DPHU-104-R
• 08800089402588: SO-35-DPHU-103-R
• 08800089402571: SO-35-DPHU-108-L
• 08800089402564: SO-35-DPHU-106-L
• 08800089402557: SO-35-DPHU-104-L
• 08800089402540: SO-35-DPHU-103-L
• 08800089402533: SO-35-DLHU-107-R
• 08800089402526: SO-35-DLHU-105-R
• 08800089402519: SO-35-DLHU-103-R
• 08800089402502: SO-35-DLHU-102-R
• 08800089402496: SO-35-DLHU-107-L
• 08800089402489: SO-35-DLHU-105-L
• 08800089402472: SO-35-DLHU-103-L
• 08800089402465: SO-35-DLHU-102-L
• 08800089402458: SO-35-DMHU-206-R
• 08800089402441: SO-35-DMHU-204-R
• 08800089402434: SO-35-DMHU-202-R
• 08800089402427: SO-35-DMHU-201-R
• 08800089402410: SO-35-DMHU-206-L
• 08800089402403: SO-35-DMHU-204-L
• 08800089402397: SO-35-DMHU-202-L
• 08800089402380: SO-35-DMHU-201-L
• 08800089402373: SO-35-PLUL-105-R
• 08800089402366: SO-35-PLUL-104-R
• 08800089402359: SO-35-PLUL-105-L
• 08800089402342: SO-35-PLUL-104-L
• 08800089402335: SO-35-PLUL-008-R
• 08800089402328: SO-35-PLUL-007-R
• 08800089402311: SO-35-PLUL-005-R
• 08800089402304: SO-35-PLUL-004-R
• 08800089402298: SO-35-PLUL-008-L
• 08800089402281: SO-35-PLUL-007-L
• 08800089402274: SO-35-PLUL-005-L
• 08800089402267: SO-35-PLUL-004-L
• 08800089402250: SO-25-PLUL-109
• 08800089402243: SO-25-PLUL-107
• 08800089402236: SO-25-PLUL-106
• 08800089402229: SO-25-PLUL-105
• 08800089402212: SO-25-PLUL-009
• 08800089402205: SO-25-PLUL-007
• 08800089402199: SO-25-PLUL-006
• 08800089402182: SO-25-PLUL-005
• 08800089402175: SO-20-PLRA-310
• 08800089402168: SO-20-PLRA-308
• 08800089402151: SO-20-PLRA-210
• 08800089402144: SO-20-PLRA-208
• 08800089402137: SO-20-PLRA-109
• 08800089402120: SO-20-PLRA-107