WaveForm™ L WL1-145010

GUDID 10889981258016

Lateral Implant, 18mm x 14mm x 50mm, 10 Deg, 3D

SEASPINE ORTHOPEDICS CORPORATION

Metallic spinal interbody fusion cage

• Primary Device ID: 10889981258016
• NIH Device Record Key: 7e4891ef-4130-466b-b0fe-abb4b91d9cf5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WaveForm™ L
• Version Model Number: WL1-145010
• Catalog Number: WL1-145010
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10889981258016 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201755

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

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: 2021-07-22
• Device Publish Date: 2021-07-14

On-Brand Devices [WaveForm™ L]

• 10889981259013: Lateral Implant, 23mm x 8mm x 55mm, 10 Deg, 3D
• 10889981258993: Lateral Implant, 23mm x 8mm x 50mm, 10 Deg, 3D
• 10889981258979: Lateral Implant, 23mm x 8mm x 45mm, 10 Deg, 3D
• 10889981258757: Lateral Implant, 23mm x 14mm x 55mm, 15 Deg, 3D
• 10889981258740: Lateral Implant, 23mm x 14mm x 55mm, 10 Deg, 3D
• 10889981258726: Lateral Implant, 23mm x 14mm x 50mm, 15 Deg, 3D
• 10889981258719: Lateral Implant, 23mm x 14mm x 50mm, 10 Deg, 3D
• 10889981258696: Lateral Implant, 23mm x 14mm x 45mm, 15 Deg, 3D
• 10889981258689: Lateral Implant, 23mm x 14mm x 45mm, 10 Deg, 3D
• 10889981258603: Lateral Implant, 23mm x 12mm x 55mm, 15 Deg, 3D
• 10889981258597: Lateral Implant, 23mm x 12mm x 55mm, 10 Deg, 3D
• 10889981258573: Lateral Implant, 23mm x 12mm x 50mm, 15 Deg, 3D
• 10889981258566: Lateral Implant, 23mm x 12mm x 50mm, 10 Deg, 3D
• 10889981258542: Lateral Implant, 23mm x 12mm x 45mm, 15 Deg, 3D
• 10889981258535: Lateral Implant, 23mm x 12mm x 45mm, 10 Deg, 3D
• 10889981258450: Lateral Implant, 23mm x 10mm x 55mm, 15 Deg, 3D
• 10889981258429: Lateral Implant, 23mm x 10mm x 50mm, 15 Deg, 3D
• 10889981258412: Lateral Implant, 23mm x 10mm x 50mm, 10 Deg, 3D
• 10889981258399: Lateral Implant, 23mm x 10mm x 45mm, 15 Deg, 3D
• 10889981258382: Lateral Implant, 23mm x 10mm x 45mm, 10 Deg, 3D
• 10889981258313: Lateral Implant, 18mm x 8mm x 55mm, 10 Deg, 3D
• 10889981258290: Lateral Implant, 18mm x 8mm x 50mm, 10 Deg, 3D
• 10889981258276: Lateral Implant, 18mm x 8mm x 45mm, 10 Deg, 3D
• 10889981258054: Lateral Implant, 18mm x 14mm x 55mm, 15 Deg, 3D
• 10889981258047: Lateral Implant, 18mm x 14mm x 55mm, 10 Deg, 3D
• 10889981258023: Lateral Implant, 18mm x 14mm x 50mm, 15 Deg, 3D
• 10889981258016: Lateral Implant, 18mm x 14mm x 50mm, 10 Deg, 3D
• 10889981257996: Lateral Implant, 18mm x 14mm x 45mm, 15 Deg, 3D
• 10889981257989: Lateral Implant, 18mm x 14mm x 45mm, 10 Deg, 3D
• 10889981257903: Lateral Implant, 18mm x 12mm x 55mm, 15 Deg, 3D
• 10889981257897: Lateral Implant, 18mm x 12mm x 55mm, 10 Deg, 3D
• 10889981257873: Lateral Implant, 18mm x 12mm x 50mm, 15 Deg, 3D
• 10889981257866: Lateral Implant, 18mm x 12mm x 50mm, 10 Deg, 3D
• 10889981257842: Lateral Implant, 18mm x 12mm x 45mm, 15 Deg, 3D
• 10889981257835: Lateral Implant, 18mm x 12mm x 45mm, 10 Deg, 3D
• 10889981257750: Lateral Implant, 18mm x 10mm x 55mm, 15 Deg, 3D
• 10889981257743: Lateral Implant, 18mm x 10mm x 55mm, 10 Deg, 3D
• 10889981257729: Lateral Implant, 18mm x 10mm x 50mm, 15 Deg, 3D
• 10889981257712: Lateral Implant, 18mm x 10mm x 50mm, 10 Deg, 3D
• 10889981257699: Lateral Implant, 18mm x 10mm x 45mm, 15 Deg, 3D
• 10889981257682: Lateral Implant, 18mm x 10mm x 45mm, 10 Deg, 3D
• 10889981258443: Lateral Implant, 23mm x 10mm x 55mm, 10 Deg, 3D