POYA 3.5mm Posteromedial Tibia Plate, Right

GUDID 07640187461794

Bonebridge AG

Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable

• Primary Device ID: 07640187461794
• NIH Device Record Key: 32e6460d-7fb0-42e2-b20a-1859a7c809d1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: POYA 3.5mm Posteromedial Tibia Plate, Right
• Version Model Number: B-222000
• 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	07640187461794 [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: 3
• Public Version Date: 2023-09-18
• Device Publish Date: 2022-12-23

Devices Manufactured by Bonebridge AG

• 07640187460049 - Variable Angle Locking Screw ø2.5mm L10mm: 2024-02-19
• 07640187460056 - Variable Angle Locking Screw ø2.5mm L12mm: 2024-02-19
• 07640187460063 - Variable Angle Locking Screw ø2.5mm L14mm: 2024-02-19
• 07640187460070 - Variable Angle Locking Screw ø2.5mm L16mm: 2024-02-19
• 07640187460087 - Variable Angle Locking Screw ø2.5mm L18mm: 2024-02-19
• 07640187460094 - Variable Angle Locking Screw ø2.5mm L20mm: 2024-02-19
• 07640187460100 - Variable Angle Locking Screw ø2.5mm L22mm: 2024-02-19
• 07640187460117 - Variable Angle Locking Screw ø2.5mm L24mm: 2024-02-19