XLIF

GUDID 00195377016911

XLIF AMS Plate, 10mm Single-Sided

Nuvasive, Inc.

Polymeric spinal interbody fusion cage

• Primary Device ID: 00195377016911
• NIH Device Record Key: edb5e60d-1b2a-4e65-89f6-2bd9603ca46b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: XLIF
• Version Model Number: 1910110P2
• 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: true
• Expiration Date: true
• 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	00195377016911 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200953

FDA Product Code

• PHM: Intervertebral fusion device with bone graft, thoracic

Sterilization

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

[00195377016911]

Radiation Sterilization

[00195377016911]

Radiation Sterilization

[00195377016911]

Radiation Sterilization

[00195377016911]

Radiation Sterilization

[00195377016911]

Radiation Sterilization

[00195377016911]

Radiation Sterilization

[00195377016911]

Radiation Sterilization

[00195377016911]

Radiation Sterilization

[00195377016911]

Radiation Sterilization

[00195377016911]

Radiation Sterilization

[00195377016911]

Radiation Sterilization

[00195377016911]

Radiation Sterilization

[00195377016911]

Radiation Sterilization

[00195377016911]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-12-08
• Device Publish Date: 2020-11-30

On-Brand Devices [XLIF]

• 00887517526540: XLIF Thoracic Ins Set
• 00887517526465: XLIF Revision Ins Set
• 00887517526335: XLIF Long Ins Set
• 00887517526328: XLIF Instruments 2
• 00887517526311: XLIF Instruments 1
• 00887517526281: XLIF Corpectomy Ins Set
• 00887517526267: XLIF Angled Ins Set
• 00887517526243: XLIF II Ins Set
• 00887517517357: 40MM Guided Broach Set
• 00887517517258: BETA MaXcess Pin Traction Set
• 00887517516039: ALPHA XLIF Slide Set
• 00887517515995: Alpha XLIF Instruments 2
• 00887517515988: Alpha XLIF Instruments 1
• 00887517504180: XLIF Corpectomy Osteotome, 25mm
• 00887517504173: XLIF Corpectomy Osteotome, 15mm
• 00887517504081: XLIF Corp Blade, 90mm Lung Retractor Nrw
• 00887517504074: XLIF Corp Blade, 80mm Lung Retractor Nrw
• 00887517464972: XLIF Rasp, 14mm Offset
• 00887517464965: XLIF Curette, Ring Offset Up Down
• 00887517464958: XLIF Cutter, 8x14mm Annulus Offset
• 00887517464941: XLIF Cutter, 6x14mm Annulus Offset
• 00887517464934: XLIF Cobb, Offset Right
• 00887517464927: XLIF Cobb, Offset Left
• 00887517464910: XLIF Curette, 45° Down Large
• 00887517464903: XLIF Curette, 45° Up Large
• 00887517464590: XLIF Curette, 90° Down Large
• 00887517464583: XLIF Curette, 90° Up Large
• 00887517464576: XLIF Curette, 45° Down Small
• 00887517464569: XLIF Curette, 45° Up Small
• 00887517464552: XLIF Curette, 90° Down Small
• 00887517464545: XLIF Curette, 90° Up Small
• 00887517461377: ALGI Cobb, Down Large Short
• 00887517461360: ALGI Cobb, Down Small Short
• 00887517461353: ALGI Cobb, 8° Angled Down Small
• 00887517461346: ALGI Cobb, 8° Angled Up Small
• 00887517461339: ALGI Cobb, 8° Angled Down Large
• 00887517461322: ALGI Cobb, 8° Angled Up Large
• 00887517453105: XLIF Pituitary, Angled Left Medium
• 00887517452795: XLIF Pituitary, Angled Right Medium
• 00887517452788: XLIF Pituitary, Large
• 00887517452771: XLIF Pituitary, Medium
• 00887517452764: XLIF Pituitary, Small
• 00887517452757: XLIF Kerrison, 5mm
• 00887517452740: XLIF Kerrison, 2mm
• 00887517418616: CoRoent XLT Inserter Trial, Long
• 00887517417282: XLIF Annulus Cutter, 6x22mm Angled
• 00887517417275: XLIF Annulus Cutter, 6x18mm Angled
• 00887517417268: XLIF Annulus Cutter, 6x16mm Angled
• 00887517417251: XLIF Annulus Cutter, 6x14mm Angled
• 00887517417244: XLIF Annulus Cutter, 4x22mm Angled