Shoreline RT 85-6211

GUDID 10889981163921

Interbody, 16x14x11mm, 10 Degree, RT

SEASPINE ORTHOPEDICS CORPORATION

Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage

• Primary Device ID: 10889981163921
• NIH Device Record Key: 9c96f141-2361-4a98-b027-cbb9787866da
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Shoreline RT
• Version Model Number: 85-6211
• Catalog Number: 85-6211
• 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: 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(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10889981163921 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183083

FDA Product Code

• OVE: Intervertebral fusion device with integrated fixation, cervical

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-03-25
• Device Publish Date: 2021-03-17

On-Brand Devices [Shoreline RT]

• 10889981164393: Interbody, 20x15x12mm, 15 Degree, RT
• 10889981164386: Interbody, 20x15x11mm, 15 Degree, RT
• 10889981164379: Interbody, 20x15x10mm, 15 Degree, RT
• 10889981164362: Interbody, 20x15x9mm, 15 Degree, RT
• 10889981164355: Interbody, 20x15x8mm, 15 Degree, RT
• 10889981164348: Interbody, 20x15x12mm, 10 Degree, RT
• 10889981164331: Interbody, 20x15x11mm, 10 Degree, RT
• 10889981164324: Interbody, 20x15x10mm, 10 Degree, RT
• 10889981164317: Interbody, 20x15x9mm, 10 Degree, RT
• 10889981164300: Interbody, 20x15x8mm, 10 Degree, RT
• 10889981164294: Interbody, 20x15x7mm, 10 Degree, RT
• 10889981164287: Interbody, 20x15x6mm, 10 Degree, RT
• 10889981164270: Interbody, 20x15x12mm, 7 Degree, RT
• 10889981164263: Interbody, 20x15x11mm, 7 Degree, RT
• 10889981164256: Interbody, 20x15x10mm, 7 Degree, RT
• 10889981164249: Interbody, 20x15x9mm, 7 Degree, RT
• 10889981164232: Interbody, 20x15x8mm, 7 Degree, RT
• 10889981164225: Interbody, 20x15x7mm, 7 Degree, RT
• 10889981164218: Interbody, 20x15x6mm, 7 Degree, RT
• 10889981164201: Interbody, 20x15x5mm, 7 Degree, RT
• 10889981164195: Interbody, 18x15x12mm, 15 Degree, RT
• 10889981164188: Interbody, 18x15x11mm, 15 Degree, RT
• 10889981164171: Interbody, 18x15x10mm, 15 Degree, RT
• 10889981164164: Interbody, 18x15x9mm, 15 Degree, RT
• 10889981164157: Interbody, 18x15x8mm, 15 Degree, RT
• 10889981164140: Interbody, 18x15x12mm, 10 Degree, RT
• 10889981164133: Interbody, 18x15x11mm, 10 Degree, RT
• 10889981164126: Interbody, 18x15x10mm, 10 Degree, RT
• 10889981164119: Interbody, 18x15x9mm, 10 Degree, RT
• 10889981164102: Interbody, 18x15x8mm, 10 Degree, RT
• 10889981164096: Interbody, 18x15x7mm, 10 Degree, RT
• 10889981164089: Interbody, 18x15x6mm, 10 Degree, RT
• 10889981164072: Interbody, 18x15x12mm, 7 Degree, RT
• 10889981164065: Interbody, 18x15x11mm, 7 Degree, RT
• 10889981164058: Interbody, 18x15x10mm, 7 Degree, RT
• 10889981164041: Interbody, 18x15x9mm, 7 Degree, RT
• 10889981164034: Interbody, 18x15x8mm, 7 Degree, RT
• 10889981164027: Interbody, 18x15x7mm, 7 Degree, RT
• 10889981164010: Interbody, 18x15x6mm, 7 Degree, RT
• 10889981164003: Interbody, 18x15x5mm, 7 Degree, RT
• 10889981163990: Interbody, 16x14x12mm, 15 Degree, RT
• 10889981163983: Interbody, 16x14x11mm, 15 Degree, RT
• 10889981163976: Interbody, 16x14x10mm, 15 Degree, RT
• 10889981163969: Interbody, 16x14x9mm, 15 Degree, RT
• 10889981163952: Interbody, 16x14x8mm, 15 Degree, RT
• 10889981163945: Interbody, 16x14x7mm, 15 Degree, RT
• 10889981163938: Interbody, 16x14x12mm, 10 Degree, RT
• 10889981163921: Interbody, 16x14x11mm, 10 Degree, RT
• 10889981163914: Interbody, 16x14x10mm, 10 Degree, RT
• 10889981163907: Interbody, 16x14x9mm, 10 Degree, RT