VuePoint

GUDID 00887517826923

VuePoint II Screw/Set Screw, 4.0x12mm FA

Nuvasive, Inc.

Bone-screw internal spinal fixation system, sterile

• Primary Device ID: 00887517826923
• NIH Device Record Key: fb52cab4-a672-495b-95cf-bee5427a2425
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VuePoint
• Version Model Number: 8980312P3
• 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: +1800-475-9131
• Email: nuvainfo@globusmedical.com
• Phone: +1800-475-9131
• Email: nuvainfo@globusmedical.com
• Phone: +1800-475-9131
• Email: nuvainfo@globusmedical.com
• Phone: +1800-475-9131
• Email: nuvainfo@globusmedical.com
• Phone: +1800-475-9131
• Email: nuvainfo@globusmedical.com
• Phone: +1800-475-9131
• Email: nuvainfo@globusmedical.com
• Phone: +1800-475-9131
• Email: nuvainfo@globusmedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887517826923 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180198

FDA Product Code

• KWP: APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Sterilization

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

[00887517826923]

Radiation Sterilization

[00887517826923]

Radiation Sterilization

[00887517826923]

Radiation Sterilization

[00887517826923]

Radiation Sterilization

[00887517826923]

Radiation Sterilization

[00887517826923]

Radiation Sterilization

[00887517826923]

Radiation Sterilization

[00887517826923]

Radiation Sterilization

[00887517826923]

Radiation Sterilization

[00887517826923]

Radiation Sterilization

[00887517826923]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-04-16
• Device Publish Date: 2019-04-08

On-Brand Devices [VuePoint]

• 00887517525505: VuePoint 10mm Smooth Screw Set
• 00887517525468: VuePoint OCT Occipital Set
• 00887517525390: VuePoint OCT Ins Set
• 00887517525376: VuePoint OCT Imp Set
• 00887517525369: VuePoint Cobalt Chromium Tray
• 00887517525338: VuePoint II Mini Add on Tray
• 00887517525307: VuePoint II Tray Occipital
• 00887517525291: VuePoint II Tray 2
• 00887517525284: VuePoint II Tray 1
• 00887517515926: VuePoint II Alpha Case 2
• 00887517515919: VuePoint II Alpha Case 1
• 00887517460691: VuePoint Plate Bender, Keel
• 00887517450074: VuePoint® II Conn, 25mm Offset
• 00887517450067: VuePoint® II Conn, 15mm Offset
• 00887517450050: VuePoint® II Conn, 11mm Offset
• 00887517450043: VuePoint® II Conn, 9mm Offset
• 00887517403001: VP II Set Screw, Rod-Rod Conn
• 00887517402691: VP II Set Screw, Offset Occipital Conn
• 00887517402660: VP II Screw, 5.0x14mm Occipital
• 00887517402653: VP II Screw, 5.0x12mm Occipital
• 00887517402646: VP II Screw, 5.0x10mm Occipital
• 00887517402639: VP II Screw, 5.0x8mm Occipital
• 00887517402622: VP II Screw, 5.0x6mm Occipital
• 00887517402608: VP II Screw, 4.5x14mm Occipital
• 00887517402394: VP II Screw, 4.5x12mm Occipital
• 00887517402387: VP II Screw, 4.5x10mm Occipital
• 00887517402370: VP II Screw, 4.5x8mm Occipital
• 00887517402363: VP II Screw, 4.5x6mm Occipital
• 00887517402356: VuePoint II Eyelets, Low Profile
• 00887517402332: VP II Conn, 3.5-5.5mm Inline Rod
• 00887517402318: VP II Conn, 3.5-3.5mm Inline Rod
• 00887517402301: VP II Conn, 45° Acute Angle Offset
• 00887517401892: VP II Conn, 25mm Offset Open Long
• 00887517401885: VuePoint® II Connector, 11mm Offset Open
• 00887517401878: VuePoint® II Hook, 8.0mm Laminar
• 00887517401861: VuePoint® II Hook, 6.0mm Laminar
• 00887517401854: VP II Screw, 3.5x36mm FA Part Thread
• 00887517401847: VP II Screw, 3.5x34mm FA Part Thread
• 00887517401830: VP II Screw, 3.5x32mm FA Part Thread
• 00887517401823: VP II Screw, 3.5x30mm FA Part Thread
• 00887517401816: VP II Screw, 3.5x28mm FA Part Thread
• 00887517401809: VP II Screw, 3.5x26mm FA Part Thread
• 00887517401496: VP II Screw, 3.5x24mm FA Part Thread
• 00887517401403: VuePoint® II Screw, 4.5x40mm MA
• 00887517400994: VuePoint® II Screw, 4.5x38mm MA
• 00887517400987: VuePoint® II Screw, 4.5x36mm MA
• 00887517400970: VuePoint® II Screw, 4.5x34mm MA
• 00887517400963: VuePoint® II Screw, 4.5x32mm MA
• 00887517400956: VuePoint® II Screw, 4.5x30mm MA
• 00887517400949: VuePoint® II Screw, 4.5x28mm MA