Cortical Screw Ø3.5mm L100mm

GUDID 07640187461268

Bonebridge AG

Orthopaedic bone screw (non-sliding)

• Primary Device ID: 07640187461268
• NIH Device Record Key: 237ce8bc-2cce-4341-a06c-12d9e1e48ffe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cortical Screw Ø3.5mm L100mm
• Version Model Number: B-324100
• 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: false
• 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	07640187461268 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K250933

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

[07640187461268]

Moist Heat or Steam Sterilization

[07640187461268]

Moist Heat or Steam Sterilization

[07640187461268]

Moist Heat or Steam Sterilization

[07640187461268]

Moist Heat or Steam Sterilization

[07640187461268]

Moist Heat or Steam Sterilization

[07640187461268]

Moist Heat or Steam Sterilization

[07640187461268]

Moist Heat or Steam Sterilization

[07640187461268]

Moist Heat or Steam Sterilization

[07640187461268]

Moist Heat or Steam Sterilization

[07640187461268]

Moist Heat or Steam Sterilization

[07640187461268]

Moist Heat or Steam Sterilization

[07640187461268]

Moist Heat or Steam Sterilization

[07640187461268]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-08-01
• Device Publish Date: 2025-07-24

Devices Manufactured by Bonebridge AG

• 07640187461251 - Cortical Screw Ø3.5mm L95mm: 2025-08-01
• 07640187461268 - Cortical Screw Ø3.5mm L100mm: 2025-08-01
• 07640187461268 - Cortical Screw Ø3.5mm L100mm: 2025-08-01
• 07640187460179 - Variable Angle Locking Screw Ø2.5mm L36mm: 2025-07-31
• 07640187460186 - Variable Angle Locking Screw Ø2.5mm L38mm: 2025-07-31
• 07640187460193 - Variable Angle Locking Screw Ø2.5mm L40mm: 2025-07-31
• 07640187460209 - Variable Angle Locking Screw Ø2.5mm L42mm: 2025-07-31
• 07640187460216 - Variable Angle Locking Screw Ø2.5mm L44mm: 2025-07-31
• 07640187460223 - Variable Angle Locking Screw Ø2.5mm L46mm: 2025-07-31