Redondo-L 36-4610

GUDID 10889981035075

45mm x 18mm x 10mm, 0 Deg

SEASPINE ORTHOPEDICS CORPORATION

Vertebral body prosthesis, non-sterile Vertebral body prosthesis, non-sterile

• Primary Device ID: 10889981035075
• NIH Device Record Key: f3c054e0-e478-44fd-92c1-9602d62f27a1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Redondo-L
• Version Model Number: 36-4610
• Catalog Number: 36-4610
• 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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10889981035075 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103297

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

Sterilization

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

[10889981035075]

Moist Heat or Steam Sterilization

[10889981035075]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-04-18

On-Brand Devices [Redondo-L]

• 10889981120504: Redondo-L 0 Deg Implant and Instrument Tray
• 10889981092122: Redondo-L 8 Deg Implant and Instrument Tray
• 10889981092115: Redondo-L Implant Caddy, 55 mm x 18 mm, 0 Deg
• 10889981092108: Redondo-L Implant Caddy, 50 mm x 18 mm, 0 Deg
• 10889981092092: Redondo-L Implant Caddy, 45 mm x 18 mm, 0 Deg
• 10889981092085: Redondo-L Implant Caddy, 40 mm x 18 mm, 0 Deg
• 10889981092078: Redondo-L Implant Caddy, 55 mm x 18 mm, 8 Deg
• 10889981092061: Redondo-L Implant Caddy, 50 mm x 18 mm, 8 Deg
• 10889981092054: Redondo-L Implant Caddy, 45 mm x 18 mm, 8 Deg
• 10889981092047: Redondo-L Implant Caddy, 40 mm x 18 mm, 8 Deg
• 10889981035334: 55mm x 18mm x 14mm, 0 Deg
• 10889981035273: 55mm x 18mm x 14mm, 8 Deg
• 10889981035082: 45mm x 18mm x 12mm, 0 Deg
• 10889981035075: 45mm x 18mm x 10mm, 0 Deg