Helix

GUDID 00887517135599

Helix R Plate, 50mm 3-Level

Nuvasive, Inc.

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 00887517135599
• NIH Device Record Key: 6bea4323-e049-47bc-9eae-de30eb5e2271
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Helix
• Version Model Number: 7800350
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887517135599 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093804

FDA Product Code

• KWQ: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Sterilization

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

[00887517135599]

Moist Heat or Steam Sterilization

[00887517135599]

Moist Heat or Steam Sterilization

[00887517135599]

Moist Heat or Steam Sterilization

[00887517135599]

Moist Heat or Steam Sterilization

[00887517135599]

Moist Heat or Steam Sterilization

[00887517135599]

Moist Heat or Steam Sterilization

[00887517135599]

Moist Heat or Steam Sterilization

[00887517135599]

Moist Heat or Steam Sterilization

[00887517135599]

Moist Heat or Steam Sterilization

[00887517135599]

Moist Heat or Steam Sterilization

[00887517135599]

Moist Heat or Steam Sterilization

[00887517135599]

Moist Heat or Steam Sterilization

[00887517135599]

Moist Heat or Steam Sterilization

[00887517135599]

Moist Heat or Steam Sterilization

[00887517135599]

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

On-Brand Devices [Helix]

• 00887517519122: Helix Mini Plate Set
• 00887517519108: Helix-T Pos Eng DTS Guides Set
• 00887517519092: Helix Family Self-Centering Tack Set
• 00887517519061: Helix Translational Set
• 00887517519009: Helix Revolution Plate Holding DTS Set
• 00887517518996: Helix-R Positive Engagement Driver Sets
• 00887517518972: Helix Revolution
• 00887517518958: Helix Revolution Set
• 00887517518903: Helix ACP Set
• 00887517327475: Helix Screwdriver, NV9
• 00887517319166: Helix ACP Tap, 13mm
• 00887517319142: Single Drill Guide
• 00887517149251: Helix-R Drill Bit, 2.5x10mm Power
• 00887517144416: Helix-R Template, 95mm 5-Level
• 00887517144409: Helix-R Template, 90mm 5-Level
• 00887517143990: Helix-R Template, 110mm 5-Level
• 00887517143983: Helix-R Template, 105mm 5-Level
• 00887517143976: Helix-R Template, 100mm 5-Level
• 00887517141873: Helix-R Tack, Temporary
• 00887517141330: Helix R Screw, 4.5x19mm Fixed Self-Tap
• 00887517141323: Helix R Screw, 4.5x17mm Fixed Self-Tap
• 00887517141316: Helix R Screw, 4.5x15mm Fixed Self-Tap
• 00887517141309: Helix R Screw, 4.5x13mm Fixed Self-Tap
• 00887517140890: Helix R Screw, 4.5x11mm Fixed Self-Tap
• 00887517140333: Helix R Screw, 4.5x19mm Var Self-Tap
• 00887517140326: Helix R Screw, 4.5x17mm Var Self-Tap
• 00887517140319: Helix R Screw, 4.5x15mm Var Self-Tap
• 00887517140302: Helix R Screw, 4.5x14mm Self-Tap Var
• 00887517139696: Helix R Screw, 4.5x13mm Var Self-Tap
• 00887517139689: Helix R Screw, 4.5x11mm Var Self-Tap
• 00887517139672: Helix R Screw, 4x19mm Fixed Self-Tap
• 00887517139665: Helix R Screw, 4x17mm Fixed Self-Tap
• 00887517139658: Helix R Screw, 4x15mm Fixed Self-Tap
• 00887517139641: Helix R Screw, 4x13mm Fixed Self-Tap
• 00887517139634: Helix R Screw, 4x11mm Fixed Self-Tap
• 00887517138965: Helix R Screw, 4x19mm Var Self-Tap
• 00887517138958: Helix R Screw, 4x17mm Var Self-Tap
• 00887517138941: Helix R Screw, 4.0x16mm Self-Tap Var
• 00887517138934: Helix R Screw, 4x15mm Var Self-Tap
• 00887517138927: Helix R Screw, 4.0x14mm Self-Tap Var
• 00887517138910: Helix R Screw, 4x13mm Var Self-Tap
• 00887517138903: Helix R Screw, 4.0x12mm Self-Tap Var
• 00887517138491: Helix R Screw, 4x11mm Var Self-Tap
• 00887517138484: Helix R Screw, 4x10mm Var Self-Tap
• 00887517138477: Helix R Screw, 4x15mm Fixed Self-Drill
• 00887517138460: Helix R Screw, 4x13mm Fixed Self-Drill
• 00887517138453: Helix R Screw, 4x11mm Fixed Self-Drill
• 00887517137982: Helix R Screw, 4x19mm Var Self-Drill
• 00887517137968: Helix R Screw, 4x17mm Var Self-Drill
• 00887517137951: Helix R Screw, 4x16mm Var Self-Drill