Summa Orthopaedics Diaphysis System Bone Plate

GUDID 08806390867184

Jeil Medical Corporation

Orthopaedic fixation plate, non-bioabsorbable

• Primary Device ID: 08806390867184
• NIH Device Record Key: 1480dfd0-eeb4-4678-988d-c2a2e9564614
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Summa Orthopaedics Diaphysis System Bone Plate
• Version Model Number: SO-35-DIST-209
• 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	08806390867184 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171285

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

[08806390867184]

Moist Heat or Steam Sterilization

[08806390867184]

Moist Heat or Steam Sterilization

[08806390867184]

Moist Heat or Steam Sterilization

[08806390867184]

Moist Heat or Steam Sterilization

[08806390867184]

Moist Heat or Steam Sterilization

[08806390867184]

Moist Heat or Steam Sterilization

[08806390867184]

Moist Heat or Steam Sterilization

[08806390867184]

Moist Heat or Steam Sterilization

[08806390867184]

Moist Heat or Steam Sterilization

[08806390867184]

Moist Heat or Steam Sterilization

[08806390867184]

Moist Heat or Steam Sterilization

[08806390867184]

Moist Heat or Steam Sterilization

[08806390867184]

Moist Heat or Steam Sterilization

[08806390867184]

Moist Heat or Steam Sterilization

[08806390867184]

Moist Heat or Steam Sterilization

[08806390867184]

Moist Heat or Steam Sterilization

[08806390867184]

Moist Heat or Steam Sterilization

[08806390867184]

Moist Heat or Steam Sterilization

[08806390867184]

Moist Heat or Steam Sterilization

[08806390867184]

Moist Heat or Steam Sterilization

[08806390867184]

Moist Heat or Steam Sterilization

[08806390867184]

Moist Heat or Steam Sterilization

[08806390867184]

Moist Heat or Steam Sterilization

[08806390867184]

Moist Heat or Steam Sterilization

[08806390867184]

Moist Heat or Steam Sterilization

[08806390867184]

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: 2018-05-03

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

• 08806390867276: SO-35V-DIST-116
• 08806390867269: SO-35V-DIST-114
• 08806390867252: SO-35V-DIST-112
• 08806390867245: SO-35V-DIST-110
• 08806390867238: SO-35V-DIST-108
• 08806390867221: SO-35V-DIST-106
• 08806390867214: SO-35-DIST-212
• 08806390867207: SO-35-DIST-211
• 08806390867191: SO-35-DIST-210
• 08806390867184: SO-35-DIST-209
• 08806390867177: SO-35-DIST-208
• 08806390867160: SO-35-DIST-207
• 08806390867153: SO-35-DIST-206
• 08806390867146: SO-35V-DIST-312
• 08806390867139: SO-35V-DIST-311
• 08806390867122: SO-35V-DIST-310
• 08806390867115: SO-35V-DIST-309
• 08806390867108: SO-35V-DIST-308
• 08806390867092: SO-35V-DIST-307
• 08806390867085: SO-35V-DIST-306
• 08806390867078: SO-35V-DIST-305
• 08806390867061: SO-35V-DIST-304