03037114

GUDID 07611819642676

125 DEG AIMING ARM STATIC+DYNAMIC DISTAL LOCKING

Synthes GmbH

Orthopaedic implant aiming arm

• Primary Device ID: 07611819642676
• NIH Device Record Key: 79cb78a3-5f1d-4824-a90e-de3b9044a80e
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 03.037.114
• Catalog Number: 03037114
• Company DUNS: 486711679
• Company Name: Synthes GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• 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

Customer Support Contacts

• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	07611819642676 [Direct Marking]
GS1	10886982344380 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131548

FDA Product Code

• HSB: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Sterilization

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

[07611819642676]

Moist Heat or Steam Sterilization

[07611819642676]

Moist Heat or Steam Sterilization

[07611819642676]

Moist Heat or Steam Sterilization

[07611819642676]

Moist Heat or Steam Sterilization

[07611819642676]

Moist Heat or Steam Sterilization

[07611819642676]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-06-27
• Device Publish Date: 2025-06-19

Devices Manufactured by Synthes GmbH

• 07611819642669 - NA: 2025-06-27 130 DEG AIMING ARM STATIC+DYNAMIC DISTAL LOCKING
• 07611819642676 - NA: 2025-06-27125 DEG AIMING ARM STATIC+DYNAMIC DISTAL LOCKING
• 07611819642676 - NA: 2025-06-27 125 DEG AIMING ARM STATIC+DYNAMIC DISTAL LOCKING
• 07611819655522 - NA: 2025-06-27 135 DEG AIMING ARM STATIC+DYNAMIC DISTAL LOCKING
• 10886982348159 - NA: 2025-06-27 5.0MM BLUNTED POINT SCHANZ SCREW 45MM THRD/175MM/HA STER
• 10886982348166 - NA: 2025-06-27 5.0MM BLUNTED POINT SCHANZ SCREW 45MM THRD/250MM/HA STER
• 10886982348173 - NA: 2025-06-27 5.0MM BLUNTED POINT SCHANZ SCREW 50MM THRD/175MM/HA STER
• 10886982348180 - NA: 2025-06-27 5.0MM BLUNTED POINT SCHANZ SCREW 50MM THRD/250MM/HA STER
• 10886982348197 - NA: 2025-06-27 6.0MM BLUNTED POINT SCHANZ SCREW 45MM THRD/175MM/HA STER