Cambria™ 93-9217

GUDID 10889981054533

Trial, Large, 8.5 in 15mm x 13mm x 7mm

SEASPINE ORTHOPEDICS CORPORATION

Spinal implant trial

• Primary Device ID: 10889981054533
• NIH Device Record Key: 5c3c3d97-d7f1-4b50-aa3c-06d2b04a262b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cambria™
• Version Model Number: 93-9217
• Catalog Number: 93-9217
• 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	10889981054533 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082309

FDA Product Code

• ODP: Intervertebral fusion device with bone graft, cervical

Sterilization

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

[10889981054533]

Moist Heat or Steam Sterilization

[10889981054533]

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: 2015-09-24

On-Brand Devices [Cambria™]

• 10889981143756: Cambria Implant, 17 x 13 x 12mm, Lordotic, Flat
• 10889981143749: Cambria Implant, 17 x 13 x 11mm, Lordotic, Flat
• 10889981143732: Cambria Implant, 17 x 13 x 10mm, Lordotic, Flat
• 10889981143725: Cambria Implant, 17 x 13 x 9mm, Lordotic, Flat
• 10889981143718: Cambria Implant, 17 x 13 x 8mm, Lordotic, Flat
• 10889981143701: Cambria Implant, 17 x 13 x 7mm, Lordotic, Flat
• 10889981143695: Cambria Implant, 17 x 13 x 6mm, Lordotic, Flat
• 10889981143688: Cambria Implant, 17 x 13 x 5mm, Lordotic, Flat
• 10889981143671: Cambria Implant, 15 x 13 x 12mm, Lordotic, Flat
• 10889981143664: Cambria Implant, 15 x 13 x 11mm, Lordotic, Flat
• 10889981143657: Cambria Implant, 15 x 13 x 10mm, Lordotic, Flat
• 10889981143640: Cambria Implant, 15 x 13 x 9mm, Lordotic, Flat
• 10889981143633: Cambria Implant, 15 x 13 x 8mm, Lordotic, Flat
• 10889981143626: Cambria Implant, 15 x 13 x 7mm, Lordotic, Flat
• 10889981143619: Cambria Implant, 15 x 13 x 6mm, Lordotic, Flat
• 10889981143602: Cambria Implant, 15 x 13 x 5mm, Lordotic, Flat
• 10889981143596: Cambria Implant, 13 x 12 x 12mm, Lordotic, Flat
• 10889981143589: Cambria Implant, 13 x 12 x 11mm, Lordotic, Flat
• 10889981143572: Cambria Implant, 13 x 12 x 10mm, Lordotic, Flat
• 10889981143565: Cambria Implant, 13 x 12 x 9mm, Lordotic, Flat
• 10889981143558: Cambria Implant, 13 x 12 x 8mm, Lordotic, Flat
• 10889981143541: Cambria Implant, 13 x 12 x 7mm, Lordotic, Flat
• 10889981143534: Cambria Implant, 13 x 12 x 6mm, Lordotic, Flat
• 10889981143527: Cambria Implant, 13 x 12 x 5mm, Lordotic, Flat
• 10889981120535: Trial, Small, 8.5in, 13mm x 12mm x 12mm
• 10889981092986: Cambria Trial, Large 15mm x 13mm x 5mm
• 10889981092979: Trial, Small, 8.5in, 13mm x 12mm x 11mm
• 10889981092962: Trial, Small, 8.5in, 13mm x 12mm x 10mm
• 10889981062224: Cambria Implant
• 10889981062217: Cambria Flat Implant
• 10889981062200: Cambria 17mm Implant
• 10889981058180: Trial, 13mm x 12mm x 12mm, Flat
• 10889981058173: Trial, 13mm x 12mm x 11mm, Flat
• 10889981058166: Trial, 13mm x 12mm x 10mm, Flat
• 10889981058159: Trial, 13mm x 12mm x 9mm, Flat
• 10889981058142: Trial, 13mm x 12mm x 8mm, Flat
• 10889981058135: Trial, 13mm x 12mm x 7mm, Flat
• 10889981058128: Trial, 13mm x 12mm x 6mm, Flat
• 10889981058111: Trial, 13mm x 12mm x 5mm, Flat
• 10889981058104: Trial, Small w/ Stop 13mm x 12mm x 12mm
• 10889981058098: Trial, Small w/ Stop 13mm x 12mm x 11mm
• 10889981058081: Trial, Small w/ Stop 13mm x 12mm x 10mm
• 10889981058074: Trial, Small w/ Stop 13mm x 12mm x 9mm
• 10889981058067: Trial, Small w/ Stop 13mm x 12mm x 8mm
• 10889981058050: Trial, Small w/ Stop 13mm x 12mm x 7mm
• 10889981058043: Trial, Small w/ Stop 13mm x 12mm x 6mm
• 10889981058036: Trial, Small w/ Stop 13mm x 12mm x 5mm
• 10889981058029: Cambria Trial, Small 13mm x 12mm x 11mm
• 10889981058012: Cambria Trial, Small 13mm x 12mm x 10mm
• 10889981058005: Cambria Implant, 17mm x 13mm x 12mm, Lordotic