APX

GUDID 00887517453693

XLIF® APX, 12x26x50mm 0°

Nuvasive, Inc.

Vertebral body prosthesis, non-sterile

• Primary Device ID: 00887517453693
• NIH Device Record Key: 0458e084-db8e-4212-8635-cca4c58d2f3f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: APX
• Version Model Number: 1672379
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887517453693 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130820
• Premarket Notification: K140162

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

Sterilization

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

[00887517453693]

Moist Heat or Steam Sterilization

[00887517453693]

Moist Heat or Steam Sterilization

[00887517453693]

Moist Heat or Steam Sterilization

[00887517453693]

Moist Heat or Steam Sterilization

[00887517453693]

Moist Heat or Steam Sterilization

[00887517453693]

Moist Heat or Steam Sterilization

[00887517453693]

Moist Heat or Steam Sterilization

[00887517453693]

Moist Heat or Steam Sterilization

[00887517453693]

Moist Heat or Steam Sterilization

[00887517453693]

Moist Heat or Steam Sterilization

[00887517453693]

Moist Heat or Steam Sterilization

[00887517453693]

Moist Heat or Steam Sterilization

[00887517453693]

Moist Heat or Steam Sterilization

[00887517453693]

Moist Heat or Steam Sterilization

[00887517453693]

Moist Heat or Steam Sterilization

[00887517453693]

Moist Heat or Steam Sterilization

[00887517453693]

Moist Heat or Steam Sterilization

[00887517453693]

Moist Heat or Steam Sterilization

[00887517453693]

Moist Heat or Steam Sterilization

[00887517453693]

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: 2015-10-24

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• 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