Cambria™ NanoMetalene® 93-9852

GUDID 10889981093990

Cambria NM Trial w/ Depth Stop, Flat 15x13, 12mm

SEASPINE ORTHOPEDICS CORPORATION

Spinal implant trial

• Primary Device ID: 10889981093990
• NIH Device Record Key: 2b53dd75-421a-4a65-b988-7651b7ab99bf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cambria™ NanoMetalene®
• Version Model Number: 93-9852
• Catalog Number: 93-9852
• Company DUNS: 079840876
• Company Name: SEASPINE ORTHOPEDICS CORPORATION
• 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(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10889981093990 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142488

FDA Product Code

• ODP: Intervertebral fusion device with bone graft, cervical

Sterilization

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

[10889981093990]

Moist Heat or Steam Sterilization

[10889981093990]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-02-07
• Device Publish Date: 2015-10-16

On-Brand Devices [Cambria™ NanoMetalene®]

• 10889981121556: Cambria NM Implant and Instrument BOM
• 10889981120566: Cambria NM 17x13 Implant Caddy
• 10889981120115: Cambria NM Implant, 13mm x 12mm x 11mm, Lordotic, Flat
• 10889981094072: Cambria NM Trial w/ Depth Stop, Flat 17x13, 12mm
• 10889981094065: Cambria NM Trial w/ Depth Stop, Flat 17x13, 11mm
• 10889981094058: Cambria NM Trial w/ Depth Stop, Flat 17x13, 10mm
• 10889981094041: Cambria NM Trial w/ Depth Stop, Flat 17x13, 9mm
• 10889981094034: Cambria NM Trial w/ Depth Stop, Flat 17x13, 8mm
• 10889981094027: Cambria NM Trial w/ Depth Stop, Flat 17x13, 7mm
• 10889981094010: Cambria NM Trial w/ Depth Stop, Flat 17x13, 6mm
• 10889981094003: Cambria NM Trial w/ Depth Stop, Flat 17x13, 5mm
• 10889981093990: Cambria NM Trial w/ Depth Stop, Flat 15x13, 12mm
• 10889981093983: Cambria NM Trial w/ Depth Stop, Flat 15x13, 11mm
• 10889981093976: Cambria NM Trial w/ Depth Stop, Flat 15x13, 10mm
• 10889981093969: Cambria NM Trial w/ Depth Stop, Flat 15x13, 9mm
• 10889981093952: Cambria NM Trial w/ Depth Stop, Flat 15x13, 8mm
• 10889981093945: Cambria NM Trial w/ Depth Stop, Flat 15x13, 7mm
• 10889981093938: Cambria NM Trial w/ Depth Stop, Flat 15x13, 6mm
• 10889981093921: Cambria NM Trial w/ Depth Stop, Flat 15x13, 5mm
• 10889981093914: Cambria NM Trial w/ Depth Stop, Flat 13x12, 12mm
• 10889981093907: Cambria NM Trial w/ Depth Stop, Flat 13x12, 11mm
• 10889981093891: Cambria NM Trial w/ Depth Stop, Flat 13x12, 10mm
• 10889981093884: Cambria NM Trial w/ Depth Stop, Flat 13x12, 9mm
• 10889981093877: Cambria NM Trial w/ Depth Stop, Flat 13x12, 8mm
• 10889981093860: Cambria NM Trial w/ Depth Stop, Flat 13x12, 7mm
• 10889981093853: Cambria NM Trial w/ Depth Stop, Flat 13x12, 6mm
• 10889981093846: Cambria NM Trial w/ Depth Stop, Flat 13x12, 5mm
• 10889981093792: Cambria NM Implant Inserter
• 10889981093464: Cambria NM 15x13 Implant Caddy
• 10889981093457: Cambria NM 13x12 Implant Caddy
• 10889981065058: Cambria NM Implant, 17x13, 12mm, Flat, Lordotic
• 10889981065041: Cambria NM Implant, 17x13, 11mm, Flat, Lordotic
• 10889981065034: Cambria NM Implant, 17x13, 10mm, Flat, Lordotic
• 10889981065027: Cambria NM Implant, 17x13, 9mm, Flat, Lordotic
• 10889981065010: Cambria NM Implant, 17x13, 8mm, Flat, Lordotic
• 10889981065003: Cambria NM Implant, 17x13, 7mm, Flat, Lordotic
• 10889981064990: Cambria NM Implant, 17x13, 6mm, Flat, Lordotic
• 10889981064983: Cambria NM Implant, 17x13, 5mm, Flat, Lordotic
• 10889981064976: Cambria NM Implant, 15x13, 12mm, Flat, Lordotic
• 10889981064969: Cambria NM Implant, 15x13, 11mm, Flat, Lordotic
• 10889981064952: Cambria NM Implant, 15x13, 10mm, Flat, Lordotic
• 10889981064945: Cambria NM Implant, 15x13, 9mm, Flat, Lordotic
• 10889981064938: Cambria NM Implant, 15x13, 8mm, Flat, Lordotic
• 10889981064921: Cambria NM Implant, 15x13, 7mm, Flat, Lordotic
• 10889981064914: Cambria NM Implant, 15x13, 6mm, Flat, Lordotic
• 10889981064907: Cambria NM Implant, 15x13, 5mm, Flat, Lordotic
• 10889981064891: Cambria NM Implant, 13x12, 11mm, Flat, Lordotic
• 10889981064884: Cambria NM Implant, 13x12, 10mm, Flat, Lordotic
• 10889981064877: Cambria NM Implant, 13x12, 9mm, Flat, Lordotic
• 10889981064860: Cambria NM Implant, 13x12, 8mm, Flat, Lordotic