Halo Buttress Plate

GUDID 00887517728012

ALIF Buttress Plate, 25mm

Nuvasive, Inc.

Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 00887517728012
• NIH Device Record Key: 34bef672-b3f3-48eb-a98e-3855b881f78f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Halo Buttress Plate
• Version Model Number: 7891025
• Company DUNS: 053950783
• Company Name: Nuvasive, Inc.
• 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(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887517728012 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143065

FDA Product Code

• KWQ: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Sterilization

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

[00887517728012]

Moist Heat or Steam Sterilization

[00887517728012]

Moist Heat or Steam Sterilization

[00887517728012]

Moist Heat or Steam Sterilization

[00887517728012]

Moist Heat or Steam Sterilization

[00887517728012]

Moist Heat or Steam Sterilization

[00887517728012]

Moist Heat or Steam Sterilization

[00887517728012]

Moist Heat or Steam Sterilization

[00887517728012]

Moist Heat or Steam Sterilization

[00887517728012]

Moist Heat or Steam Sterilization

[00887517728012]

Moist Heat or Steam Sterilization

[00887517728012]

Moist Heat or Steam Sterilization

[00887517728012]

Moist Heat or Steam Sterilization

[00887517728012]

Moist Heat or Steam Sterilization

[00887517728012]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-02-08

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• 00887517789969: ALIF Buttress Plate Tray
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• 00887517728012: ALIF Buttress Plate, 25mm
• 00887517728005: ALIF Buttress Plate, 23mm
• 00887517727992: ALIF Buttress Plate, 21mm
• 00887517727985: ALIF Buttress Plate Driver, Final
• 00887517727978: ALIF Buttress Plate Screwdriver
• 00887517727961: ALIF Buttress Plate Tap, 5.75mm
• 00887517727954: ALIF Buttress Plate Tap, 4.75mm
• 00887517727947: ALIF Buttress Plate Bender