03010489

GUDID H679030104890

AIMING ARM FOR RETROGRADE SPIRAL BLADE LOCKING

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: H679030104890
• NIH Device Record Key: 10a83bca-333c-4b67-a956-42a896222c97
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 03.010.489
• Catalog Number: 03010489
• 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	07611819498884 [Direct Marking]
GS1	10886982069078 [Primary]
HIBCC	H679030104890 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K033618

FDA Product Code

• HSB: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Sterilization

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

[H679030104890]

Moist Heat or Steam Sterilization

[H679030104890]

Moist Heat or Steam Sterilization

[H679030104890]

Moist Heat or Steam Sterilization

[H679030104890]

Moist Heat or Steam Sterilization

[H679030104890]

Moist Heat or Steam Sterilization

[H679030104890]

Moist Heat or Steam Sterilization

[H679030104890]

Moist Heat or Steam Sterilization

[H679030104890]

Moist Heat or Steam Sterilization

[H679030104890]

Moist Heat or Steam Sterilization

[H679030104890]

Moist Heat or Steam Sterilization

[H679030104890]

Moist Heat or Steam Sterilization

[H679030104890]

Moist Heat or Steam Sterilization

[H679030104890]

Moist Heat or Steam Sterilization

[H679030104890]

Moist Heat or Steam Sterilization

[H679030104890]

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

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• 10886982344236 - NA: 2024-05-13 FOOT - 4MM UPRIGHT REDUCTION CLAMP
• 10886982344243 - NA: 2024-05-13 HOOK - 4MM UPRIGHT REDUCTION CLAMP
• 10886982344250 - NA: 2024-05-13 HOOK - 10MM UPRIGHT REDUCTION CLAMP
• 10886982346940 - NA: 2024-05-09 60MM DEPTH PROBE FOR XL25 SCREWS
• 10886982346933 - NA: 2024-05-08 EXTENDED MULTI HOLE WIRE GUIDE FOR RFNA
• 10886982346957 - NA: 2024-05-08 FNS ANGLED GUIDE 130° W/ WIDER BASE
• 10887587078359 - NA: 2024-04-16 MANDIBLE BODY REDUCTION HANDLE