SALGINA 2.5mm Volar Distal Radius Plate, Distal Wide, 3 Hole, Left

GUDID 07640187462692

Bonebridge AG

Orthopaedic fixation plate, non-bioabsorbable

• Primary Device ID: 07640187462692
• NIH Device Record Key: dc6943bb-de0b-43e9-b45c-98456f1c0210
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SALGINA 2.5mm Volar Distal Radius Plate, Distal Wide, 3 Hole, Left
• Version Model Number: B-111400
• 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	07640187462692 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243308

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: 2025-02-10
• Device Publish Date: 2025-01-31

Devices Manufactured by Bonebridge AG

• 07640187462616 - LEPORELLO 3.5mm Olecranon Plate 7 Hole, Left: 2025-02-10
• 07640187462623 - LEPORELLO 3.5mm Olecranon Plate 7 Hole, Right: 2025-02-10
• 07640187462630 - SALGINA 2.5mm Volar Distal Radius Plate, Standard, 3 Hole, Left: 2025-02-10
• 07640187462647 - SALGINA 2.5mm Volar Distal Radius Plate, Standard, 3 Hole, Right: 2025-02-10
• 07640187462654 - SALGINA 2.5mm Volar Distal Radius Plate, Standard, 5 Hole, Left: 2025-02-10
• 07640187462661 - SALGINA 2.5mm Volar Distal Radius Plate, Standard, 5 Hole, Right: 2025-02-10
• 07640187462678 - SALGINA 2.5mm Volar Distal Radius Plate, Distal Narrow, 3 Hole, Left: 2025-02-10
• 07640187462685 - SALGINA 2.5mm Volar Distal Radius Plate, Distal Narrow, 3 Hole, Right: 2025-02-10