04631500

GUDID H981046315000

TI MIRS POLYAXIAL SCREW BODY

SYNTHES (U.S.A.) LP

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: H981046315000
• NIH Device Record Key: ba07e704-e641-4cba-b6ec-e1e763efd0df
• Commercial Distribution Discontinuation: 2020-09-17
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 04.631.500
• Catalog Number: 04631500
• 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
• 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	10705034818009 [Primary]
HIBCC	H981046315000 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113044

FDA Product Code

• KWQ: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Sterilization

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

[H981046315000]

Moist Heat or Steam Sterilization

[H981046315000]

Moist Heat or Steam Sterilization

[H981046315000]

Moist Heat or Steam Sterilization

[H981046315000]

Moist Heat or Steam Sterilization

[H981046315000]

Moist Heat or Steam Sterilization

[H981046315000]

Moist Heat or Steam Sterilization

[H981046315000]

Moist Heat or Steam Sterilization

[H981046315000]

Moist Heat or Steam Sterilization

[H981046315000]

Moist Heat or Steam Sterilization

[H981046315000]

Moist Heat or Steam Sterilization

[H981046315000]

Moist Heat or Steam Sterilization

[H981046315000]

Moist Heat or Steam Sterilization

[H981046315000]

Moist Heat or Steam Sterilization

[H981046315000]

Moist Heat or Steam Sterilization

[H981046315000]

Moist Heat or Steam Sterilization

[H981046315000]

Moist Heat or Steam Sterilization

[H981046315000]

Moist Heat or Steam Sterilization

[H981046315000]

Moist Heat or Steam Sterilization

[H981046315000]

Moist Heat or Steam Sterilization

[H981046315000]

Moist Heat or Steam Sterilization

[H981046315000]

Moist Heat or Steam Sterilization

[H981046315000]

Moist Heat or Steam Sterilization

[H981046315000]

Moist Heat or Steam Sterilization

[H981046315000]

Moist Heat or Steam Sterilization

[H981046315000]

Moist Heat or Steam Sterilization

[H981046315000]

Moist Heat or Steam Sterilization

[H981046315000]

Moist Heat or Steam Sterilization

[H981046315000]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-08-31
• Device Publish Date: 2017-03-07

Devices Manufactured by SYNTHES (U.S.A.) LP

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• H9814871830 - Click'X: 2024-09-11 7.0MM TI CLICK'X® MONOAXIAL PEDICLE SCREW 90MM THRD LENGTH
• H9812982060 - NA: 2024-07-24 ANGLED LAMINA HOOK/ DUAL-OPENING SIDE
• H6792042280 - NA: 2024-07-24 3.5MM SHAFT SCREW 28MM
• H6792042320 - NA: 2024-07-24 3.5MM SHAFT SCREW 32MM
• H6792042340 - NA: 2024-07-24 3.5MM SHAFT SCREW 34MM
• H6792042360 - NA: 2024-07-24 3.5MM SHAFT SCREW 36MM
• H6792042380 - NA: 2024-07-24 3.5MM SHAFT SCREW 38MM