Camber

GUDID 00887517995872

Camber Graft Plate, 10mm C-C

Nuvasive, Inc.

Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 00887517995872
• NIH Device Record Key: a59a4a67-8e2a-48fa-b3f7-90cc1c017750
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Camber
• Version Model Number: 8370030P
• 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
• 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	00887517995872 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191169

FDA Product Code

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

Sterilization

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

[00887517995872]

Radiation Sterilization

[00887517995872]

Radiation Sterilization

[00887517995872]

Radiation Sterilization

[00887517995872]

Radiation Sterilization

[00887517995872]

Radiation Sterilization

[00887517995872]

Radiation Sterilization

[00887517995872]

Radiation Sterilization

[00887517995872]

Radiation Sterilization

[00887517995872]

Radiation Sterilization

[00887517995872]

Radiation Sterilization

[00887517995872]

Radiation Sterilization

[00887517995872]

Radiation Sterilization

[00887517995872]

Radiation Sterilization

[00887517995872]

Radiation Sterilization

[00887517995872]

Radiation Sterilization

[00887517995872]

Radiation Sterilization

[00887517995872]

Radiation Sterilization

[00887517995872]

Radiation Sterilization

[00887517995872]

Radiation Sterilization

[00887517995872]

Radiation Sterilization

[00887517995872]

Radiation Sterilization

[00887517995872]

Radiation Sterilization

[00887517995872]

Radiation Sterilization

[00887517995872]

Radiation Sterilization

[00887517995872]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-09-02
• Device Publish Date: 2020-08-25

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• 00887517995926: Camber Graft Plate, 12mm M-L
• 00887517995919: Camber Graft Plate, 10mm M-L
• 00887517995902: Camber Graft Plate, 8mm M-L
• 00887517995896: Camber Graft Plate, 14mm C-C
• 00887517995889: Camber Graft Plate, 12mm C-C
• 00887517995872: Camber Graft Plate, 10mm C-C
• 00887517995865: Camber Graft Plate, 8mm C-C
• 00887517995858: Camber Trad Plate, 14mm Lg Lamina M-L
• 00887517995841: Camber Trad Plate, 12mm Lg Lamina M-L
• 00887517995834: Camber Trad Plate, 10mm Lg Lamina M-L
• 00887517995827: Camber Trad Plate, 8mm Lg Lamina M-L
• 00887517995810: Camber Traditional Plate, 14mm M-L
• 00887517995803: Camber Traditional Plate, 12mm M-L
• 00887517995797: Camber Traditional Plate, 10mm M-L
• 00887517995780: Camber Traditional Plate, 8mm M-L
• 00887517995773: Camber Trad Plate, 14mm Lg Lamina C-C
• 00887517995766: Camber Trad Plate, 12mm Lg Lamina C-C
• 00887517995759: Camber Trad Plate, 10mm Lg Lamina C-C
• 00887517995742: Camber Trad Plate, 8mm Lg Lamina C-C
• 00887517995735: Camber Traditional Plate, 14mm C-C
• 00887517995728: Camber Traditional Plate, 12mm C-C
• 00887517995711: Camber Traditional Plate, 10mm C-C
• 00887517995704: Camber Traditional Plate, 8mm C-C
• 00887517995698: Camber Screw, 3.0x9mm
• 00887517995681: Camber Screw, 2.6x9mm
• 00887517994387: Camber LS Loading Block, Primary Plate
• 00887517994370: Camber LS Measurement Device
• 00887517994363: Camber LS Trial Plate, 14mm
• 00887517994356: Camber LS Trial Plate, 12mm
• 00887517994349: Camber LS Trial Plate, 10mm
• 00887517994332: Camber LS Trial Plate, 8mm
• 00887517994325: Camber LS Lamina Holder
• 00887517994318: Camber LS Drill, 7mm
• 00887517994301: Camber LS Drill, 5mm
• 00887517994295: Camber LS Screwdriver, Stab-n-Grab
• 00887517994288: Camber LS Plate Holder, Fixed