Explorer TO ET1-303208

GUDID 10889981206567

Height Expansion, 9mm x 32mm x 8-12mm, 0 Deg

SEASPINE ORTHOPEDICS CORPORATION

Metal-polymer composite spinal interbody fusion cage

• Primary Device ID: 10889981206567
• NIH Device Record Key: ae781f5a-f9e6-48bd-b60d-5d6aa23054f3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Explorer TO
• Version Model Number: ET1-303208
• Catalog Number: ET1-303208
• 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
• 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
• 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
• 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	10889981206567 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193418

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

Sterilization

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

[10889981206567]

Moist Heat or Steam Sterilization

[10889981206567]

Moist Heat or Steam Sterilization

[10889981206567]

Moist Heat or Steam Sterilization

[10889981206567]

Moist Heat or Steam Sterilization

[10889981206567]

Moist Heat or Steam Sterilization

[10889981206567]

Moist Heat or Steam Sterilization

[10889981206567]

Moist Heat or Steam Sterilization

[10889981206567]

Moist Heat or Steam Sterilization

[10889981206567]

Moist Heat or Steam Sterilization

[10889981206567]

Moist Heat or Steam Sterilization

[10889981206567]

Moist Heat or Steam Sterilization

[10889981206567]

Moist Heat or Steam Sterilization

[10889981206567]

Moist Heat or Steam Sterilization

[10889981206567]

Moist Heat or Steam Sterilization

[10889981206567]

Moist Heat or Steam Sterilization

[10889981206567]

Moist Heat or Steam Sterilization

[10889981206567]

Moist Heat or Steam Sterilization

[10889981206567]

Moist Heat or Steam Sterilization

[10889981206567]

Moist Heat or Steam Sterilization

[10889981206567]

Moist Heat or Steam Sterilization

[10889981206567]

Moist Heat or Steam Sterilization

[10889981206567]

Moist Heat or Steam Sterilization

[10889981206567]

Moist Heat or Steam Sterilization

[10889981206567]

Moist Heat or Steam Sterilization

[10889981206567]

Moist Heat or Steam Sterilization

[10889981206567]

Moist Heat or Steam Sterilization

[10889981206567]

Moist Heat or Steam Sterilization

[10889981206567]

Moist Heat or Steam Sterilization

[10889981206567]

Moist Heat or Steam Sterilization

[10889981206567]

Moist Heat or Steam Sterilization

[10889981206567]

Moist Heat or Steam Sterilization

[10889981206567]

Moist Heat or Steam Sterilization

[10889981206567]

Moist Heat or Steam Sterilization

[10889981206567]

Moist Heat or Steam Sterilization

[10889981206567]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-09-09
• Device Publish Date: 2020-09-01

On-Brand Devices [Explorer TO]

• 10889981220723: Caddy - Height Expansion, 9mm Width
• 10889981220716: Caddy - Lordosis Expansion, 9mm Width
• 10889981220709: Tray - Bottom Level
• 10889981220693: Tray - Top Level
• 10889981220686: Tray - Base
• 10889981210854: 12mm Trial, 9mm Wide, Centered
• 10889981210847: 10mm Trial, 9mm Wide, Centered
• 10889981210830: 8mm Trial, 9mm Wide, Centered
• 10889981210809: Torque Limiting Handle, 22.5in-lb
• 10889981207335: Syringe Adapter
• 10889981207328: Bone Cartridge Pusher
• 10889981207304: Bone Cartridge Base
• 10889981207298: Bone Delivery Rack Plunger
• 10889981207281: Bone Delivery Tower
• 10889981207274: Bone Cartridge
• 10889981207267: Auger
• 10889981207250: Slap Hammer
• 10889981207243: 12mm Trial, 9mm Wide
• 10889981207236: 10mm Trial, 9mm Wide
• 10889981207229: 8mm Trial, 9mm Wide
• 10889981207212: 6mm Trial, 9mm Wide
• 10889981207199: Height Expansion Driver
• 10889981207182: Lordosis Expansion Driver
• 10889981207168: Inserter Wrench
• 10889981207151: Impaction Cap
• 10889981207144: Inserter Handle
• 10889981207137: Inserter
• 10889981206772: Height Expansion, 9mm x 32mm x 12-16mm, 8 Deg
• 10889981206758: Height Expansion, 9mm x 32mm x 10-14mm, 8 Deg
• 10889981206741: Height Expansion, 9mm x 28mm x 12-16mm, 8 Deg
• 10889981206727: Height Expansion, 9mm x 28mm x 10-14mm, 8 Deg
• 10889981206604: Height Expansion, 9mm x 32mm x 12-16mm, 0 Deg
• 10889981206581: Height Expansion, 9mm x 32mm x 10-14mm, 0 Deg
• 10889981206567: Height Expansion, 9mm x 32mm x 8-12mm, 0 Deg
• 10889981206550: Height Expansion, 9mm x 32mm x 7-11mm, 0 Deg
• 10889981206543: Height Expansion, 9mm x 28mm x 12-16mm, 0 Deg
• 10889981206529: Height Expansion, 9mm x 28mm x 10-14mm, 0 Deg
• 10889981206505: Height Expansion, 9mm x 28mm x 8-12mm, 0 Deg
• 10889981206499: Height Expansion, 9mm x 28mm x 7-11mm, 0 Deg
• 10889981206482: Lordosis Expansion, 9x30x10mm, 3-17 Deg
• 10889981206475: Lordosis Expansion, 9x26x10mm, 3-17 Deg
• 10889981206468: Lordosis Expansion, 9x26x12mm, 6-20 Deg
• 10889981184919: Lordosis Expansion, 9x30x8mm, 0-14 Deg
• 10889981184902: Lordosis Expansion, 9x26x8mm, 0-14 Deg
• 10889981184896: Lordosis Expansion, 9x30x12mm, 6-20 Deg
• 10889981292348: Bone Delivery Rack Plunger
• 10889981289560: Caddy - Height Expansion, 9mm Width
• 10889981289553: Caddy - Lordosis Expansion, 9mm Width
• 10889981289546: Inserter Wrench
• 10889981289300: Tray - Bottom Level