APX

GUDID 00887517514820

Alpha AP Expandable XLIF Graft Delivery

Nuvasive, Inc.

Sterilization/disinfection container Sterilization/disinfection container Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable

• Primary Device ID: 00887517514820
• NIH Device Record Key: ae20f4f8-8c6f-4e4f-8167-908e74d24438
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: APX
• Version Model Number: ALPAPXGRFT
• 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: 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(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
• 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	00887517514820 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143579

FDA Product Code

• KCT: Sterilization wrap containers, trays, cassettes & other accessories

Sterilization

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

[00887517514820]

Moist Heat or Steam Sterilization

[00887517514820]

Moist Heat or Steam Sterilization

[00887517514820]

Moist Heat or Steam Sterilization

[00887517514820]

Moist Heat or Steam Sterilization

[00887517514820]

Moist Heat or Steam Sterilization

[00887517514820]

Moist Heat or Steam Sterilization

[00887517514820]

Moist Heat or Steam Sterilization

[00887517514820]

Moist Heat or Steam Sterilization

[00887517514820]

Moist Heat or Steam Sterilization

[00887517514820]

Moist Heat or Steam Sterilization

[00887517514820]

Moist Heat or Steam Sterilization

[00887517514820]

Moist Heat or Steam Sterilization

[00887517514820]

Moist Heat or Steam Sterilization

[00887517514820]

Moist Heat or Steam Sterilization

[00887517514820]

Moist Heat or Steam Sterilization

[00887517514820]

Moist Heat or Steam Sterilization

[00887517514820]

Moist Heat or Steam Sterilization

[00887517514820]

Moist Heat or Steam Sterilization

[00887517514820]

Moist Heat or Steam Sterilization

[00887517514820]

Moist Heat or Steam Sterilization

[00887517514820]

Moist Heat or Steam Sterilization

[00887517514820]

Moist Heat or Steam Sterilization

[00887517514820]

Moist Heat or Steam Sterilization

[00887517514820]

Moist Heat or Steam Sterilization

[00887517514820]

Moist Heat or Steam Sterilization

[00887517514820]

Moist Heat or Steam Sterilization

[00887517514820]

Moist Heat or Steam Sterilization

[00887517514820]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-09-10
• Device Publish Date: 2016-09-23

On-Brand Devices [APX]

• 00887517514844: Alpha AP Expandable XLIF Instrument Set
• 00887517514837: Alpha AP Expandable XLIF Implant Set
• 00887517514820: Alpha AP Expandable XLIF Graft Delivery
• 00887517454072: XLIF® APX, 12x30x55mm 10°
• 00887517454065: XLIF® APX, 12x26x55mm 10°
• 00887517454058: XLIF® APX, 10x30x55mm 10°
• 00887517454041: XLIF® APX, 10x26x55mm 10°
• 00887517454034: XLIF® APX, 8x30x55mm 10°
• 00887517454027: XLIF® APX, 8x26x55mm 10°
• 00887517454010: XLIF® APX, 12x30x50mm 10°
• 00887517454003: XLIF® APX, 12x26x50mm 10°
• 00887517453693: XLIF® APX, 12x26x50mm 0°
• 00887517453686: XLIF® APX, 10x30x50mm 10°
• 00887517451903: XLIF® APX, 10x26x50mm 10°
• 00887517451590: XLIF® APX, 10x26x50mm 0°
• 00887517451583: XLIF® APX, 8x30x50mm 10°
• 00887517451576: XLIF® APX, 8x26x50mm 10°
• 00887517451569: XLIF® APX, 8x26x50mm 0°
• 00887517210173: XLIF APX Inserter, Expandable
• 00887517184764: XLIF® APX, 12x30x55mm 0°
• 00887517184757: XLIF® APX, 10X30X55mm 0°
• 00887517184740: XLIF® APX, 8X30X55mm 0°
• 00887517211811: XLIF APX Rod, 26x55mm
• 00887517211019: XLIF APX Rod, 30x55mm
• 00887517211002: XLIF APX Rod, 26x50mm
• 00887517199805: XLIF APX Shim, Long
• 00887517211422: XLIF APX Template, 26x50mm
• 00887517210593: XLIF APX Template, 30x55mm
• 00887517210586: XLIF APX Template, 30x50mm
• 00887517210579: XLIF APX Template, 30x50mm
• 00887517453617: XLIF APX Tray, PA Base Level