CASCELLA 3.5mm Superior Clavicle Plate, Lateral, 12 Hole, Left

GUDID 07640187461763

Bonebridge AG

Orthopaedic fixation plate, non-bioabsorbable, sterile

• Primary Device ID: 07640187461763
• NIH Device Record Key: ff56e509-5120-4717-8a61-cf13df0464bf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CASCELLA 3.5mm Superior Clavicle Plate, Lateral, 12 Hole, Left
• Version Model Number: B-131110
• 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	07640187461763 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213864

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-01-13
• Device Publish Date: 2022-12-23

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• 07640187462395 - SALTI 3.5mm Anterolateral Distal Tibia Plate, 11 Hole, Right: 2025-01-23
• 07640187462401 - SALTI 3.5mm Medial Distal Tibia Plate, 8 Hole, Left: 2025-01-23
• 07640187462418 - SALTI 3.5mm Medial Distal Tibia Plate, 8 Hole, Right: 2025-01-23
• 07640187462425 - SALTI 3.5mm Medial Distal Tibia Plate, 11 Hole, Left: 2025-01-23
• 07640187462432 - SALTI 3.5mm Medial Distal Tibia Plate, 11 Hole, Right: 2025-01-23