04614639

GUDID H981046146390

3.5MM TI TOP LOADING OCCIPITAL FUSION CONNECTOR/90DEG

SYNTHES (U.S.A.) LP

Bone-screw internal spinal fixation system connector Bone-screw internal spinal fixation system connector Bone-screw internal spinal fixation system connector Bone-screw internal spinal fixation system connector Bone-screw internal spinal fixation system connector Bone-screw internal spinal fixation system connector Bone-screw internal spinal fixation system connector Bone-screw internal spinal fixation system connector Bone-screw internal spinal fixation system connector Bone-screw internal spinal fixation system connector Bone-screw internal spinal fixation system connector Bone-screw internal spinal fixation system connector Bone-screw internal spinal fixation system connector Bone-screw internal spinal fixation system connector Bone-screw internal spinal fixation system connector Bone-screw internal spinal fixation system connector Bone-screw internal spinal fixation system connector

• Primary Device ID: H981046146390
• NIH Device Record Key: ab0e4614-82e4-431e-8efa-b65cfbdedd93
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 04.614.639
• Catalog Number: 04614639
• Company DUNS: 832637081
• Company Name: SYNTHES (U.S.A.) LP
• 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
• 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	10705034739526 [Primary]
HIBCC	H981046146390 [Secondary]

FDA Product Code

• KWP: APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Sterilization

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

[H981046146390]

Moist Heat or Steam Sterilization

[H981046146390]

Moist Heat or Steam Sterilization

[H981046146390]

Moist Heat or Steam Sterilization

[H981046146390]

Moist Heat or Steam Sterilization

[H981046146390]

Moist Heat or Steam Sterilization

[H981046146390]

Moist Heat or Steam Sterilization

[H981046146390]

Moist Heat or Steam Sterilization

[H981046146390]

Moist Heat or Steam Sterilization

[H981046146390]

Moist Heat or Steam Sterilization

[H981046146390]

Moist Heat or Steam Sterilization

[H981046146390]

Moist Heat or Steam Sterilization

[H981046146390]

Moist Heat or Steam Sterilization

[H981046146390]

Moist Heat or Steam Sterilization

[H981046146390]

Moist Heat or Steam Sterilization

[H981046146390]

Moist Heat or Steam Sterilization

[H981046146390]

Moist Heat or Steam Sterilization

[H981046146390]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2024-07-12
• Device Publish Date: 2015-09-14

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• H981042006140 - Axon: 2024-07-12 3.5MM TI CANCELLOUS AXON(TM) SCREW 28MM THREAD LENGTH
• H981042006150 - Axon: 2024-07-12 3.5MM TI CANCELLOUS AXON(TM) SCREW 30MM THREAD LENGTH
• H981042006160 - Axon: 2024-07-12 3.5MM TI CANCELLOUS AXON(TM) SCREW 32MM THREAD LENGTH
• H981042006170 - Axon: 2024-07-12 3.5MM TI CANCELLOUS AXON(TM) SCREW 34MM THREAD LENGTH
• H981042006180 - Axon: 2024-07-12 3.5MM TI CANCELLOUS AXON(TM) SCREW 36MM THREAD LENGTH
• H981042006190 - Axon: 2024-07-12 3.5MM TI CANCELLOUS AXON(TM) SCREW 38MM THREAD LENGTH