VersaTie

GUDID 00887517984289

VersaTie PET Band, 5.5mm Malleable End

Nuvasive, Inc.

Bone-screw internal spinal fixation system, sterile

• Primary Device ID: 00887517984289
• NIH Device Record Key: 7c26182f-9706-46ec-b4fb-f00e1e6aa11a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VersaTie
• Version Model Number: 86101155
• 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
• 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	00887517984289 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161265

FDA Product Code

• OWI: Bone fixation cerclage, sublaminar

Sterilization

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

[00887517984289]

Radiation Sterilization

[00887517984289]

Radiation Sterilization

[00887517984289]

Radiation Sterilization

[00887517984289]

Radiation Sterilization

[00887517984289]

Radiation Sterilization

[00887517984289]

Radiation Sterilization

[00887517984289]

Radiation Sterilization

[00887517984289]

Radiation Sterilization

[00887517984289]

Radiation Sterilization

[00887517984289]

Radiation Sterilization

[00887517984289]

Radiation Sterilization

[00887517984289]

Radiation Sterilization

[00887517984289]

Radiation Sterilization

[00887517984289]

Radiation Sterilization

[00887517984289]

Radiation Sterilization

[00887517984289]

Radiation Sterilization

[00887517984289]

Radiation Sterilization

[00887517984289]

Radiation Sterilization

[00887517984289]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-12-16
• Device Publish Date: 2019-12-06

On-Brand Devices [VersaTie]

• 00887517948564: VersaTie Clamp, 5/6.0mm Rod
• 00887517984289: VersaTie PET Band, 5.5mm Malleable End
• 00887517984784: VersaTie Clamp, 5/6.0mm Rod
• 00887517953131: VersaTie Bone Punch
• 00887517948595: VersaTie Tensioner
• 00887517984296: VersaTie PET Band, 4.5mm Hook End
• 00887517953100: VersaTie Handle, Dual Sided
• 00887517948588: VersaTie Driver, Lock Screw
• 00887517948571: VersaTie Driver, Lock Nut
• 00887517824493: VersaTie Sterile Packed 4.5mm Bands
• 00887517794857: VersaTie Band, 4.5mm Hook-Malleable End
• 00887517763976: Alpha VersaTie Clamps & Instruments
• 00887517721525: VersaTie Band, 5.5mm Dual Malleable End
• 00887517709875: VersaTie Clamp, 5-6mm Side Loading
• 00887517960214: VersaTie Base, Ancillary Tray
• 00887517953117: VersaTie Base, Tray