Summa Orthopaedics Hand System Bone Plate

GUDID 08806390868877

Jeil Medical Corporation

Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable

• Primary Device ID: 08806390868877
• NIH Device Record Key: 85de99ba-5870-4363-a202-57a02c34c434
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Summa Orthopaedics Hand System Bone Plate
• Version Model Number: SO-H2L-TP-010-13
• 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	08806390868877 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161746

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

[08806390868877]

Moist Heat or Steam Sterilization

[08806390868877]

Moist Heat or Steam Sterilization

[08806390868877]

Moist Heat or Steam Sterilization

[08806390868877]

Moist Heat or Steam Sterilization

[08806390868877]

Moist Heat or Steam Sterilization

[08806390868877]

Moist Heat or Steam Sterilization

[08806390868877]

Moist Heat or Steam Sterilization

[08806390868877]

Moist Heat or Steam Sterilization

[08806390868877]

Moist Heat or Steam Sterilization

[08806390868877]

Moist Heat or Steam Sterilization

[08806390868877]

Moist Heat or Steam Sterilization

[08806390868877]

Moist Heat or Steam Sterilization

[08806390868877]

Moist Heat or Steam Sterilization

[08806390868877]

Moist Heat or Steam Sterilization

[08806390868877]

Moist Heat or Steam Sterilization

[08806390868877]

Moist Heat or Steam Sterilization

[08806390868877]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2024-06-04
• Device Publish Date: 2018-04-30

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

• 08806390868914: SO-H2L-LR-010-13
• 08806390868907: SO-H2L-LL-010-13
• 08806390868891: SO-H2L-LR-006-13
• 08806390868884: SO-H2L-LL-006-13
• 08806390868877: SO-H2L-TP-010-13
• 08806390868860: SO-H2L-TP-006-13
• 08806390868853: SO-H2L-ST-208-13
• 08806390868846: SO-H2L-ST-106-13
• 08806390868839: SO-H2L-ST-105-13
• 08806390868822: SO-H2L-ST-104-13
• 08806390868815: SO-H2L-LR-006
• 08806390868808: SO-H2L-LL-006
• 08806390868792: SO-H2L-YP-007
• 08806390868785: SO-H2L-YP-006
• 08806390868778: SO-H2L-TP-007
• 08806390868761: SO-H2L-QD-006
• 08806390868754: SO-H2L-ST-016
• 08806390868747: SO-H2L-ST-006
• 08806390868730: SO-H2L-ST-004
• 08806390868723: SO-H1L-LR-005
• 08806390868716: SO-H1L-LL-005
• 08806390868709: SO-H1L-YP-006
• 08806390868693: SO-H1L-TP-007
• 08806390868686: SO-H1L-QD-112
• 08806390868679: SO-H1L-ST-104
• 08806390868662: SO-H1L-ST-016
• 08806390868655: SO-H1L-ST-006
• 08806390863964: SO-F35-CR-112-13
• 08806390863957: SO-F35-CL-112-13
• 08806390863940: SO-F35-CR-012-13
• 08806390863933: SO-F35-CL-012-13
• 08806390863926: SO-F35-CR-009
• 08806390863919: SO-F35-CL-009
• 08806390863902: SO-F28-TP-007
• 08806390863896: SO-F28-TP-006
• 08806390863889: SO-F28-HP-010
• 08806390863872: SO-F28-HL-109
• 08806390863865: SO-F28-HR-109
• 08806390863858: SO-F28-HL-009
• 08806390863841: SO-F28-HR-009
• 08806390863834: SO-F28-GR-009
• 08806390863827: SO-F28-GR-008
• 08806390863810: SO-F28-GR-007
• 08806390863803: SO-F28-ST-006
• 08806390863797: SO-F28-ST-005
• 08806390863780: SO-F28-ST-004
• 08806390863773: SO-F28-ST-102
• 08806390863766: SO-F28-ST-002