SITTER 3.5mm Versatile Plate, 7 Hole

GUDID 07640187462166

Bonebridge AG

Orthopaedic fixation plate, non-bioabsorbable

• Primary Device ID: 07640187462166
• NIH Device Record Key: f72fe025-25bc-4673-9aa6-8b3734b1089f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SITTER 3.5mm Versatile Plate, 7 Hole
• Version Model Number: B-240000
• 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	07640187462166 [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

• 07640187462166 - SITTER 3.5mm Versatile Plate, 7 Hole: 2024-10-09
• 07640187462166 - SITTER 3.5mm Versatile Plate, 7 Hole: 2024-10-09
• 07640187462173 - SITTER 3.5mm Versatile Plate, 9 Hole: 2024-10-09
• 07640187462180 - SITTER 3.5mm Versatile Plate, 11 Hole: 2024-10-09
• 07640187462333 - SITTER 3.5mm Versatile Plate, 15 Hole: 2024-10-09
• 07640187462340 - SITTER 3.5mm Versatile Plate, 19 Hole: 2024-10-09
• 07640187462357 - SITTER 3.5mm Versatile Plate, 23 Hole: 2024-10-09
• 07640187460049 - Variable Angle Locking Screw ø2.5mm L10mm: 2024-02-19
• 07640187460056 - Variable Angle Locking Screw ø2.5mm L12mm: 2024-02-19