04616130

GUDID H981046161300

5.5MM TI ROD 30MM

Synthes GmbH

Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: H981046161300
• NIH Device Record Key: c50460d4-a495-4a60-a184-ca46d21f1664
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 04.616.130
• Catalog Number: 04616130
• 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: 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705034741154 [Primary]
HIBCC	H981046161300 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092929

FDA Product Code

• MNH: Orthosis, spondylolisthesis spinal fixation

Sterilization

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

[H981046161300]

Moist Heat or Steam Sterilization

[H981046161300]

Moist Heat or Steam Sterilization

[H981046161300]

Moist Heat or Steam Sterilization

[H981046161300]

Moist Heat or Steam Sterilization

[H981046161300]

Moist Heat or Steam Sterilization

[H981046161300]

Moist Heat or Steam Sterilization

[H981046161300]

Moist Heat or Steam Sterilization

[H981046161300]

Moist Heat or Steam Sterilization

[H981046161300]

Moist Heat or Steam Sterilization

[H981046161300]

Moist Heat or Steam Sterilization

[H981046161300]

Moist Heat or Steam Sterilization

[H981046161300]

Moist Heat or Steam Sterilization

[H981046161300]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-04-26
• Device Publish Date: 2015-09-14

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