Cambria NanoMetalene 39-1606

GUDID 10889981137236

Cambria NM Implant, 15mm x 13mm x 6mm, Lordotic

SEASPINE ORTHOPEDICS CORPORATION

Vertebral body prosthesis, non-sterile Vertebral body prosthesis, non-sterile

• Primary Device ID: 10889981137236
• NIH Device Record Key: 80dfa717-b71a-4990-bf87-f254a22c5c16
• Commercial Distribution Discontinuation: 2018-05-19
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Cambria NanoMetalene
• Version Model Number: 39-1606
• Catalog Number: 39-1606
• 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: true
• 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	10889981137236 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142488

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

Sterilization

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

[10889981137236]

Moist Heat or Steam Sterilization

[10889981137236]

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: 2016-10-21

On-Brand Devices [Cambria NanoMetalene]

• 10889981137373: Cambria NM Implant, 17mm x 13mm x 12mm, Lordotic
• 10889981137366: Cambria NM Implant, 17mm x 13mm x 11mm, Lordotic
• 10889981137359: Cambria NM Implant, 17mm x 13mm x 10mm, Lordotic
• 10889981137342: Cambria NM Implant, 17mm x 13mm x 9mm, Lordotic
• 10889981137335: Cambria NM Implant, 17mm x 13mm x 8mm, Lordotic
• 10889981137328: Cambria NM Implant, 17mm x 13mm x 7mm, Lordotic
• 10889981137311: Cambria NM Implant, 17mm x 13mm x 6mm, Lordotic
• 10889981137304: Cambria NM Implant, 17mm x 13mm x 5mm, Lordotic
• 10889981137298: Cambria NM Implant, 15mm x 13mm x 12mm, Lordotic
• 10889981137281: Cambria NM Implant, 15mm x 13mm x 11mm, Lordotic
• 10889981137274: Cambria NM Implant, 15mm x 13mm x 10mm, Lordotic
• 10889981137267: Cambria NM Implant, 15mm x 13mm x 9mm, Lordotic
• 10889981137250: Cambria NM Implant, 15mm x 13mm x 8mm, Lordotic
• 10889981137243: Cambria NM Implant, 15mm x 13mm x 7mm, Lordotic
• 10889981137236: Cambria NM Implant, 15mm x 13mm x 6mm, Lordotic
• 10889981137229: Cambria NM Implant, 15mm x 13mm x 5mm, Lordotic
• 10889981120573: Cambria NM Sterilization Tray
• 10889981093839: Cambria NM Packing Block
• 10889981093822: Cambria NM Rasp
• 10889981093815: Cambria NM Graft Packer
• 10889981093808: Cambria NM Implant Tamp
• 00889981120118: Cambria NM Implant,13 x 12 x 12mm,Lordotic,Sterile
• 00889981065051: Cambria NM Implant,17 x 13 x 12mm,Lordotic,Sterile
• 00889981065044: Cambria NM Implant,17 x 13 x 11mm,Lordotic,Sterile
• 00889981065037: Cambria NM Implant,17 x 13 x 10mm,Lordotic,Sterile
• 00889981065020: Cambria NM Implant,17 x 13 x 9mm,Lordotic,Sterile
• 00889981065013: Cambria NM Implant,17 x 13 x 8mm,Lordotic,Sterile
• 00889981065006: Cambria NM Implant,17 x 13 x 7mm,Lordotic,Sterile
• 00889981064993: Cambria NM Implant,17 x 13 x 6mm,Lordotic,Sterile
• 00889981064986: Cambria NM Implant,17 x 13 x 5mm,Lordotic,Sterile
• 00889981064979: Cambria NM Implant,15 x 13 x 12mm,Lordotic,Sterile
• 00889981064962: Cambria NM Implant,15 x 13 x 11mm,Lordotic,Sterile
• 00889981064955: Cambria NM Implant,15 x 13 x 10mm,Lordotic,Sterile
• 00889981064948: Cambria NM Implant,15 x 13 x 9mm,Lordotic,Sterile
• 00889981064931: Cambria NM Implant,15 x 13 x 8mm,Lordotic,Sterile
• 00889981064924: Cambria NM Implant,15 x 13 x 7mm,Lordotic,Sterile
• 00889981064917: Cambria NM Implant,15 x 13 x 6mm,Lordotic,Sterile
• 00889981064900: Cambria NM Implant,15 x 13 x 5mm,Lordotic,Sterile
• 00889981064894: Cambria NM Implant,13 x 12 x 11mm,Lordotic,Sterile
• 00889981064887: Cambria NM Implant,13 x 12 x 10mm,Lordotic,Sterile
• 00889981064870: Cambria NM Implant,13 x 12 x 9mm,Lordotic,Sterile
• 00889981064863: Cambria NM Implant,13 x 12 x 8mm,Lordotic,Sterile
• 00889981064856: Cambria NM Implant,13 x 12 x 7mm,Lordotic,Sterile
• 00889981064849: Cambria NM Implant,13 x 12 x 6mm,Lordotic,Sterile
• 00889981064832: Cambria NM Implant,13 x 12 x 5mm,Lordotic,Sterile