Redondo-L™ 93-6112

GUDID 10889981035365

Redondo-L 45mm x 18mm x 8mm, 8 Deg. Redondo-L is intended to promote spinal fusion by acting as a spacer and holding bone graft. The implants have teeth on the superior and inferior surfaces and a central canal for receiving bone graft. These devices are available in a variety of lengths, widths, and heights to accommodate variations in pathology and patient anatomy. All Redondo-L implants are manufactured from PEEK OPTIMA®(polyetheretherketone, ASTM F-2026) with tantalum (ASTM F-560) radiographic wires and/or beads.

SEASPINE ORTHOPEDICS CORPORATION

Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable

• Primary Device ID: 10889981035365
• NIH Device Record Key: 17b7ec7c-8c44-4dee-979b-4414bc6532a9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Redondo-L™
• Version Model Number: 93-6112
• Catalog Number: 93-6112
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	10889981035365 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103297

FDA Product Code

• MQP: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Sterilization

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

[10889981035365]

Moist Heat or Steam Sterilization

[10889981035365]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-04-23
• Device Publish Date: 2015-09-24

On-Brand Devices [Redondo-L™]

• 10889981035365: Redondo-L 45mm x 18mm x 8mm, 8 Deg. Redondo-L is intended to promote spinal fusion by acting as
• 10889981035327: Redondo-L 45mm x 18mm x 8mm, 8 Deg.
• 10889981035310: Redondo-L 45mm x 18mm x 8mm, 8 Deg.
• 10889981035303: Redondo-L 45mm x 18mm x 8mm, 8 Deg.
• 10889981035266: Redondo-L 45mm x 18mm x 8mm, 8 Deg.
• 10889981035259: Redondo-L 45mm x 18mm x 8mm, 8 Deg.
• 10889981035242: Redondo-L 45mm x 18mm x 8mm, 8 Deg.
• 10889981035211: Redondo-L 45mm x 18mm x 8mm, 8 Deg. Redondo-L is intended to promote spinal fusion by acting as
• 10889981035204: Redondo-L 45mm x 18mm x 8mm, 8 Deg.
• 10889981035198: Redondo-L 45mm x 18mm x 8mm, 8 Deg.
• 10889981035181: Redondo-L 45mm x 18mm x 8mm, 8 Deg.
• 10889981035150: Redondo-L 45mm x 18mm x 8mm, 8 Deg.
• 10889981035143: Redondo-L 45mm x 18mm x 8mm, 8 Deg.
• 10889981035136: Redondo-L 45mm x 18mm x 8mm, 8 Deg.
• 10889981035129: Redondo-L 45mm x 18mm x 8mm, 8 Deg.
• 10889981035099: Redondo-L 45mm x 18mm x 8mm, 8 Deg.
• 10889981035068: Redondo-L 45mm x 18mm x 8mm, 8 Deg.
• 10889981035051: Redondo-L 45mm x 18mm x 8mm, 8 Deg. Redondo-L is intended to promote spinal fusion by acting as
• 10889981035044: Redondo-L 45mm x 18mm x 8mm, 8 Deg. Redondo-L is intended to promote spinal fusion by acting as
• 10889981035037: Redondo-L 45mm x 18mm x 8mm, 8 Deg.
• 10889981035020: Redondo-L 45mm x 18mm x 8mm, 8 Deg.
• 10889981035013: Redondo-L 45mm x 18mm x 8mm, 8 Deg.
• 10889981035006: Redondo-L 45mm x 18mm x 8mm, 8 Deg.