SITTER 3.5mm Versatile Plate, 11 Hole

GUDID 07640187462180

Bonebridge AG

Orthopaedic fixation plate, non-bioabsorbable

• Primary Device ID: 07640187462180
• NIH Device Record Key: d40cdf19-36a1-4bd4-9c3b-0301c1ccbc15
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SITTER 3.5mm Versatile Plate, 11 Hole
• Version Model Number: B-240200
• 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	07640187462180 [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

• 07640187462364 - SALTI 3.5mm Anterolateral Distal Tibia Plate, 8 Hole, Left: 2025-01-23
• 07640187462371 - SALTI 3.5mm Anterolateral Distal Tibia Plate, 8 Hole, Right: 2025-01-23
• 07640187462388 - SALTI 3.5mm Anterolateral Distal Tibia Plate, 11 Hole, Left: 2025-01-23
• 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