SITTER 3.5mm Versatile Plate, 19 Hole

GUDID 07640187462340

Bonebridge AG

Orthopaedic fixation plate, non-bioabsorbable

• Primary Device ID: 07640187462340
• NIH Device Record Key: 5af8625b-c7de-4f15-9c17-f80f8df6305a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SITTER 3.5mm Versatile Plate, 19 Hole
• Version Model Number: B-240400
• Company DUNS: 480244832
• Company Name: Bonebridge AG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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	07640187462340 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240318

FDA Product Code

• HRS: Plate, Fixation, Bone

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: 2024-10-09
• Device Publish Date: 2024-10-01

Devices Manufactured by Bonebridge AG

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• 07640187462777 - TAMINA 3.5mm Proximal Humerus Plate, 7 Hole, Long, Right: 2026-01-26
• 07640187463125 - Lag Screw Drill Guide 2.5mm: 2026-01-26
• 07640187463132 - Drill Bit Ø2.5mm x 140mm: 2026-01-26
• 07640187463149 - Bending Iron Small: 2026-01-26
• 07640187463156 - Bending Plier Small: 2026-01-26
• 07640187463163 - Cutting Plier: 2026-01-26
• 07640187463101 - Monoaxial Drill Guide 2.5mm: 2026-01-23