Leverage

GUDID 00887517071965

LeVerage Plate, 9.5mm Lg Laminar

Nuvasive, Inc.

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 00887517071965
• NIH Device Record Key: 52eb0696-a33f-40b3-929e-61bc7e602525
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Leverage
• Version Model Number: 7650409
• 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	00887517071965 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091623

FDA Product Code

• NQW: ORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METAL

Sterilization

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

[00887517071965]

Moist Heat or Steam Sterilization

[00887517071965]

Moist Heat or Steam Sterilization

[00887517071965]

Moist Heat or Steam Sterilization

[00887517071965]

Moist Heat or Steam Sterilization

[00887517071965]

Moist Heat or Steam Sterilization

[00887517071965]

Moist Heat or Steam Sterilization

[00887517071965]

Moist Heat or Steam Sterilization

[00887517071965]

Moist Heat or Steam Sterilization

[00887517071965]

Moist Heat or Steam Sterilization

[00887517071965]

Moist Heat or Steam Sterilization

[00887517071965]

Moist Heat or Steam Sterilization

[00887517071965]

Moist Heat or Steam Sterilization

[00887517071965]

Moist Heat or Steam Sterilization

[00887517071965]

Moist Heat or Steam Sterilization

[00887517071965]

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 [Leverage]

• 00887517520425: Leverage Laminoplasty Fixation Set
• 00887517074423: LeVerage Screw, 3x5mm Laminar
• 00887517073426: Leverage Drill Bit, 8mm
• 00887517073419: Leverage Drill Bit, 7mm
• 00887517073402: Leverage Drill Bit, 6mm
• 00887517072993: Leverage Drill Bit, 5mm
• 00887517072986: Leverage Drill Bit, 3mm
• 00887517072979: Leverage Drill Bit, 5mm Fixed
• 00887517072474: LeVerage Screw, 2.6x5mm Laminar
• 00887517072467: LeVerage Screw, 3x8mm Lateral Mass
• 00887517072450: LeVerage Screw, 3x7mm Lateral Mass
• 00887517072443: LeVerage Screw, 3x6mm Lateral Mass
• 00887517072436: LeVerage Screw, 3x5mm Lateral Mass
• 00887517072429: LeVerage Screw, 2.6x8mm Lateral Mass
• 00887517072412: LeVerage Screw, 2.6x7mm Lateral Mass
• 00887517072405: LeVerage Screw, 2.6x6mm Lateral Mass
• 00887517071996: LeVerage Screw, 2.6x5mm Lateral Mass
• 00887517071989: LeVerage Plate, 12.5mm Lg Laminar
• 00887517071972: LeVerage Plate, 11mm Lg Laminar
• 00887517071965: LeVerage Plate, 9.5mm Lg Laminar
• 00887517071958: LeVerage Plate, 8mm Lg Laminar
• 00887517071941: LeVerage Plate, 12.5mm Graft M-L
• 00887517071934: LeVerage Plate, 11mm Graft M-L
• 00887517071927: LeVerage Plate, 9.5mm Graft M-L
• 00887517071910: LeVerage Plate, 8mm Graft M-L
• 00887517071903: LeVerage Plate, 12.5mm Graft C-C
• 00887517071392: LeVerage Plate, 11mm Graft C-C
• 00887517071385: LeVerage Plate, 9.5mm Graft C-C
• 00887517071378: LeVerage Plate, 8mm Graft C-C
• 00887517071361: LeVerage Plate, 12.5mm Traditional M-L
• 00887517071354: LeVerage Plate, 11mm Traditional M-L
• 00887517071347: LeVerage Plate, 9.5mm Traditional M-L
• 00887517071330: LeVerage Plate, 8mm Traditional M-L
• 00887517071323: LeVerage Plate, 12.5mm Traditional C-C
• 00887517071316: LeVerage Plate, 11mm Traditional C-C
• 00887517071309: LeVerage Plate, 9.5mm Traditional C-C
• 00887517070890: LeVerage Plate, 8mm Traditional C-C
• 00887517072900: Leverage Holder, Needle Nose Plate
• 00887517995674: LeVerage Screw, 3x8mm Lateral Mass
• 00887517995667: LeVerage Screw, 3x7mm Lateral Mass
• 00887517995650: LeVerage Screw, 3x6mm Lateral Mass
• 00887517995643: LeVerage Screw, 3x5mm Lateral Mass
• 00887517995636: LeVerage Screw, 2.6x8mm Lateral Mass
• 00887517995629: LeVerage Screw, 2.6x7mm Lateral Mass
• 00887517995612: LeVerage Screw, 2.6x6mm Lateral Mass
• 00887517995605: LeVerage Screw, 2.6x5mm Lateral Mass
• 00887517073471: Laminoplasty Imp Sterilization Tray Base