SD357365

GUDID H679SD3573650

125/130/135 DEG AIMING ARM F/TROCHANTERIC FIXATION NAILS

Synthes GmbH

Orthopaedic implant aiming arm Orthopaedic implant aiming arm Orthopaedic implant aiming arm Orthopaedic implant aiming arm Orthopaedic implant aiming arm Orthopaedic implant aiming arm Orthopaedic implant aiming arm Orthopaedic implant aiming arm Orthopaedic implant aiming arm Orthopaedic implant aiming arm Orthopaedic implant aiming arm Orthopaedic implant aiming arm Orthopaedic implant aiming arm Orthopaedic implant aiming arm Orthopaedic implant aiming arm

• Primary Device ID: H679SD3573650
• NIH Device Record Key: 75b9ae69-231c-47fc-b1bd-4e9d91f9eab0
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: SD357.365
• Catalog Number: SD357365
• 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
• 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
• 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	10886982006011 [Primary]
HIBCC	H679SD3573650 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K011857

FDA Product Code

• HWC: Screw, fixation, bone

Sterilization

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

[H679SD3573650]

Moist Heat or Steam Sterilization

[H679SD3573650]

Moist Heat or Steam Sterilization

[H679SD3573650]

Moist Heat or Steam Sterilization

[H679SD3573650]

Moist Heat or Steam Sterilization

[H679SD3573650]

Moist Heat or Steam Sterilization

[H679SD3573650]

Moist Heat or Steam Sterilization

[H679SD3573650]

Moist Heat or Steam Sterilization

[H679SD3573650]

Moist Heat or Steam Sterilization

[H679SD3573650]

Moist Heat or Steam Sterilization

[H679SD3573650]

Moist Heat or Steam Sterilization

[H679SD3573650]

Moist Heat or Steam Sterilization

[H679SD3573650]

Moist Heat or Steam Sterilization

[H679SD3573650]

Moist Heat or Steam Sterilization

[H679SD3573650]

Moist Heat or Steam Sterilization

[H679SD3573650]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2022-04-28
• Device Publish Date: 2015-09-14

Devices Manufactured by Synthes GmbH

• 10887587078359 - NA: 2024-04-16 MANDIBLE BODY REDUCTION HANDLE
• 10886982344427 - NA: 2024-03-21 PROTECTION SLV F/NAILS/Ø8-11MM RIGID/TIBIAL FIXTN/LNG/STER
• 10886982344434 - NA: 2024-03-21 PROTECTION SLV F/NAILS/Ø8-13MM RIGID/TIBIAL FIXTN/LNG/STER
• 10886982345745 - NA: 2024-03-21 PROTECTION SLV F/NAILS/Ø8-11MM RIGID/LONG/STERILE
• 10886982345752 - NA: 2024-03-21 PROTECTION SLV F/NAILS/Ø8-13MM RIGID/LONG/STERILE
• H67904038070S0 - TFN-ADVANCE: 2024-02-27 TFNA SCREW 70MM - STERILE
• H6792161400 - NA: 2024-02-27 6.5MM CANCELLOUS BONE SCREW 16MM THREAD/140MM
• H6792180750 - NA: 2024-02-27 6.5MM CANCELLOUS BONE SCREW FULLY THREADED/75MM