Manta Ray TDF US1-200705

GUDID 10889981287672

Manta Ray TDF Spacer, 16x14x5mm, 7 Deg, Strl Asm

SEASPINE ORTHOPEDICS CORPORATION

Metal-polymer composite spinal interbody fusion cage

• Primary Device ID: 10889981287672
• NIH Device Record Key: 4af48cd8-1f6c-4e82-80b5-1c08346924d5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Manta Ray TDF
• Version Model Number: US1-200705
• Catalog Number: US1-200705
• 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
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10889981287672 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220296

FDA Product Code

• ODP: Intervertebral fusion device with bone graft, 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: 2023-08-23
• Device Publish Date: 2023-08-15

Devices Manufactured by SEASPINE ORTHOPEDICS CORPORATION

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• 10889981125844 - NewPort: 2024-12-19 NewPort 4mm Hex Screw, DIA 9.5 x 80mm
• 10889981130060 - NewPort: 2024-12-19 Newport 4mm Hex Screw, Ø5.5 x 50mm
• 10889981130077 - NewPort: 2024-12-19 Newport 4mm Hex Screw, Ø6.5 x 75mm
• 10889981130091 - NewPort: 2024-12-19 Newport 4mm Hex Screw, Ø8.5 x 30mm
• 10889981134921 - NewPort: 2024-12-19 NewPort 4mm Hex Screw, DIA 4.75 x 25mm
• 10889981134938 - NewPort: 2024-12-19 NewPort 4mm Hex Screw, DIA 4.75 x 60mm
• 10889981134945 - NewPort: 2024-12-19 NewPort 4mm Hex Screw, DIA 4.75 x 55mm