SeaSpine Spacer System - Redondo™ 36-1016

GUDID 10889981044121

Redondo Implant, 30mm x 24mm x 16mm, 10 Deg Lordotic

SEASPINE ORTHOPEDICS CORPORATION

Vertebral body prosthesis, non-sterile

• Primary Device ID: 10889981044121
• NIH Device Record Key: 4d240553-d80b-4392-b0f6-e250240a1e55
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SeaSpine Spacer System - Redondo™
• Version Model Number: 36-1016
• Catalog Number: 36-1016
• 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: false
• 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	10889981044121 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082310

FDA Product Code

• MQP: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Sterilization

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

[10889981044121]

Moist Heat or Steam Sterilization

[10889981044121]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-24

On-Brand Devices [SeaSpine Spacer System - Redondo™]

• 10889981045869: Redondo Trial 26mm x 24mm x 22mm, 8 Deg
• 10889981045852: Redondo Trial 26mm x 24mm x 20mm, 8 Deg
• 10889981045845: Redondo Trial 26mm x 24mm x 18mm, 8 Deg
• 10889981045838: Redondo Trial 26mm x 24mm x 16mm, 8 Deg
• 10889981045821: Redondo Trial 26mm x 24mm x 14mm, 8 Deg
• 10889981045814: Redondo Trial 26mm x 24mm x 12mm, 8 Deg
• 10889981045807: Redondo Trial 26mm x 24mm x 10mm, 8 Deg
• 10889981045791: Redondo Trial 38mm x 26mm x 22mm, 12 Deg
• 10889981045784: Redondo Trial 38mm x 26mm x 20mm, 12 Deg
• 10889981045777: Redondo Trial 38mm x 26mm x 18mm, 12 Deg
• 10889981045760: Redondo Trial 38mm x 26mm x 16mm, 12 Deg
• 10889981045753: Redondo Trial 38mm x 26mm x 14mm, 12 Deg
• 10889981045746: Redondo Trial 38mm x 26mm x 12mm, 12 Deg
• 10889981045739: Redondo Trial 38mm x 26mm x 10mm, 12 Deg
• 10889981045722: Redondo Trial 38mm x 26mm x 22mm, 8 Deg
• 10889981045715: Redondo Trial 38mm x 26mm x 20mm, 8 Deg
• 10889981045708: Redondo Trial 38mm x 26mm x 18mm, 8 Deg
• 10889981045692: Redondo Trial 38mm x 26mm x 16mm, 8 Deg
• 10889981045685: Redondo Trial 38mm x 26mm x 14mm, 8 Deg
• 10889981045678: Redondo Trial 38mm x 26mm x 12mm, 8 Deg
• 10889981045661: Redondo Trial 38mm x 26mm x 10mm, 8 Deg
• 10889981045654: Redondo Trial 30mm x 24mm x 22mm, 5 Deg
• 10889981045647: Redondo Trial 30mm x 24mm x 20mm, 5 Deg
• 10889981045630: Redondo Trial 30mm x 24mm x 18mm, 5 Deg
• 10889981045623: Redondo Trial 30mm x 24mm x 16mm, 5 Deg
• 10889981045616: Redondo Trial 30mm x 24mm x 14mm, 5 Deg
• 10889981045609: Redondo Trial 30mm x 24mm x 12mm, 5 Deg
• 10889981045593: Redondo Trial 30mm x 24mm x 10mm, 5 Deg
• 10889981045586: Redondo Trial 34mm x 24mm x 22mm, 12 Deg
• 10889981045579: Redondo Trial 34mm x 24mm x 20mm, 12 Deg
• 10889981045562: Redondo Trial 34mm x 24mm x 18mm, 12 Deg
• 10889981045555: Redondo Trial 34mm x 24mm x 16mm, 12 Deg
• 10889981045548: Redondo Trial 34mm x 24mm x 14mm, 12 Deg
• 10889981045531: Redondo Trial 34mm x 24mm x 12mm, 12 Deg
• 10889981045524: Redondo Trial 34mm x 24mm x 10mm, 12 Deg
• 10889981045517: Redondo Trial 34mm x 24mm x 22mm, 8 Deg
• 10889981045500: Redondo Trial 34mm x 24mm x 20mm, 8 Deg
• 10889981045494: Redondo Trial 34mm x 24mm x 18mm, 8 Deg
• 10889981045487: Redondo Trial 34mm x 24mm x 16mm, 8 Deg
• 10889981045470: Redondo Trial 34mm x 24mm x 14mm, 8 Deg
• 10889981045463: Redondo Trial 34mm x 24mm x 12mm, 8 Deg
• 10889981045456: Redondo Trial 34mm x 24mm x 10mm, 8 Deg
• 10889981045449: Trial, 30mm x 24mm x 22mm, 15 Deg Lordotic
• 10889981045432: Trial, 30mm x 24mm x 20mm, 15 Deg Lordotic
• 10889981045425: Trial, 30mm x 24mm x 18mm, 15 Deg Lordotic
• 10889981045418: Trial, 30mm x 24mm x 16mm, 15 Deg Lordotic
• 10889981045401: Trial, 30mm x 24mm x 14mm, 15 Deg Lordotic
• 10889981045395: Trial, 30mm x 24mm x 12mm, 15 Deg Lordotic
• 10889981045388: Trial, 30mm x 24mm x 22mm, 10 Deg Lordotic
• 10889981045371: Trial, 30mm x 24mm x 20mm, 10 Deg Lordotic