Radian

GUDID 00887517257154

Radian Facet Screw, 5.2x50mm

Nuvasive, Inc.

Trans-facet-screw internal spinal fixation system, sterile

• Primary Device ID: 00887517257154
• NIH Device Record Key: 141db667-c8bb-46cd-879d-0de8fa972861
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Radian
• Version Model Number: 5565250
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887517257154 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101284

FDA Product Code

• MRW: SYSTEM, FACET SCREW SPINAL DEVICE

Sterilization

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

[00887517257154]

Moist Heat or Steam Sterilization

[00887517257154]

Moist Heat or Steam Sterilization

[00887517257154]

Moist Heat or Steam Sterilization

[00887517257154]

Moist Heat or Steam Sterilization

[00887517257154]

Moist Heat or Steam Sterilization

[00887517257154]

Moist Heat or Steam Sterilization

[00887517257154]

Moist Heat or Steam Sterilization

[00887517257154]

Moist Heat or Steam Sterilization

[00887517257154]

Moist Heat or Steam Sterilization

[00887517257154]

Moist Heat or Steam Sterilization

[00887517257154]

Moist Heat or Steam Sterilization

[00887517257154]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-24

On-Brand Devices [Radian]

• 00887517521750: Radian Facet Screw Set
• 00887517518781: Triad Facet Screw Set
• 00887517259387: Radian Facet Screw, 5.2x55mm Full Thread
• 00887517259370: Radian Facet Screw, 5.2x50mm Full Thread
• 00887517259363: Radian Facet Screw, 5.2x45mm Full Thread
• 00887517259356: Radian Facet Screw, 5.2x40mm Full Thread
• 00887517259349: Radian Facet Screw, 5.2x35mm Full Thread
• 00887517259332: Radian Facet Screw, 5.2x30mm Full Thread
• 00887517259325: Radian Facet Screw, 5.2x25mm Full Thread
• 00887517257161: Radian Facet Screw, 5.2x55mm
• 00887517257154: Radian Facet Screw, 5.2x50mm
• 00887517257147: Radian Facet Screw, 5.2x45mm
• 00887517257130: Radian Facet Screw, 5.2x40mm
• 00887517257123: Radian Facet Screw, 5.2x35mm
• 00887517257116: Radian Facet Screw, 5.2x30mm
• 00887517257109: Radian Facet Screw, 5.2x25mm
• 00887517256102: Radian Facet Screw, 4.5x55mm Full Thread
• 00887517255792: Radian Facet Screw, 4.5x50mm Full Thread
• 00887517255785: Radian Facet Screw, 4.5x45mm Full Thread
• 00887517255778: Radian Facet Screw, 4.5x40mm Full Thread
• 00887517255761: Radian Facet Screw, 4.5x35mm Full Thread
• 00887517255754: Radian Facet Screw, 4.5x30mm Full Thread
• 00887517255747: Radian Facet Screw, 4.5x25mm Full Thread
• 00887517255723: Radian Facet Screw, 4.5x55mm
• 00887517255716: Radian Facet Screw, 4.5x50mm
• 00887517255709: Radian Facet Screw, 4.5x45mm
• 00887517255396: Radian Facet Screw, 4.5x40mm
• 00887517255389: Radian Facet Screw, 4.5x35mm
• 00887517255372: Radian Facet Screw, 4.5x30mm
• 00887517255365: Radian Facet Screw, 4.5x25mm
• 00887517253927: Radian Facet Tap, 4.75mm Non-Cannulated
• 00887517253484: Radian Driver, Self-Retaining
• 00887517253477: Radian Facet Screwdriver
• 00887517253088: Radian Tap, 4.75mm
• 00887517253071: Radian Tap, 4.0mm
• 00887517253064: Radian Facet Handle, Guide
• 00887517253057: Radian Facet Guide
• 00887517251091: Radian Washer, Facet Screw
• 00887517251060: FACET SCREW BOTTOM LEVEL / BASE