Regatta Lateral System 36-231650-15

GUDID 10889981159276

Lateral Implant, 23mm x 16mm x 50mm, 15 Deg

SEASPINE ORTHOPEDICS CORPORATION

Vertebral body prosthesis Vertebral body prosthesis

• Primary Device ID: 10889981159276
• NIH Device Record Key: 19a806ce-3d95-4e67-837c-a04bd2d1e9a5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Regatta Lateral System
• Version Model Number: 36-231650-15
• Catalog Number: 36-231650-15
• 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

Device Dimensions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10889981159276 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181079

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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-02-24
• Device Publish Date: 2018-09-15

On-Brand Devices [Regatta Lateral System]

• 10889987164793: Lateral Disc Prep Instrument Tray Case
• 10889987164786: Lateral Disc Prep Instrument Tray Level Bottom
• 10889987164779: Lateral Disc Prep Instrument Tray Level Top
• 10889987164762: Angled Lateral Disc Prep Instrument Tray Case
• 10889987164755: Angled Lateral Disc Prep Instrument Tray Bottom
• 10889987164748: Angled Lateral Disc Prep Instrument Tray Top
• 10889987163123: Lateral Box Cutter, 6x23mm
• 10889986163117: Lateral Box Cutter, 4x23mm
• 10889981170783: Osteophyte Biter
• 10889981170776: Down Biting Curette, Small
• 10889981163044: Trial, 23mm x 16mm x 55mm, 15 Deg
• 10889981163037: Trial, 23mm x 16mm x 55mm, 10 Deg
• 10889981163013: Trial, 23mm x 14mm x 55mm, 15 Deg
• 10889981163006: Trial, 23mm x 14mm x 55mm, 10 Deg
• 10889981162993: Trial, 23mm x 14mm x 55mm, 0 Deg
• 10889981162986: Trial, 23mm x 12mm x 55mm, 15 Deg
• 10889981162979: Trial, 23mm x 12mm x 55mm, 10 Deg
• 10889981162962: Trial, 23mm x 12mm x 55mm, 0 Deg
• 10889981162955: Trial, 23mm x 10mm x 55mm, 15 Deg
• 10889981162948: Trial, 23mm x 10mm x 55mm, 10 Deg
• 10889981162931: Trial, 23mm x 10mm x 55mm, 0 Deg
• 10889981162924: Trial, 23mm x 8mm x 55mm, 10 Deg
• 10889981162917: Trial, 23mm x 8mm x 55mm, 0 Deg
• 10889981162900: Trial, 18mm x 16mm x 55mm, 15 Deg
• 10889981162894: Trial, 18mm x 16mm x 55mm, 10 Deg
• 10889981162870: Trial, 18mm x 14mm x 55mm, 15 Deg
• 10889981162863: Trial, 18mm x 14mm x 55mm, 10 Deg
• 10889981162856: Trial, 18mm x 14mm x 55mm, 0 Deg
• 10889981162849: Trial, 18mm x 12mm x 55mm, 15 Deg
• 10889981162832: Trial, 18mm x 12mm x 55mm, 10 Deg
• 10889981162825: Trial, 18mm x 12mm x 55mm, 0 Deg
• 10889981162818: Trial, 18mm x 10mm x 55mm, 15 Deg
• 10889981162801: Trial, 18mm x 10mm x 55mm, 10 Deg
• 10889981162795: Trial, 18mm x 10mm x 55mm, 0 Deg
• 10889981162788: Trial, 18mm x 8mm x 55mm, 10 Deg
• 10889981162771: Trial, 18mm x 8mm x 55mm, 0 Deg
• 10889981162764: Regatta Instrument Tray Non-Lordotic Trial Caddy
• 10889981162757: Regatta Instrument Tray Wide Trial Caddy
• 10889981162740: Regatta Instrument Tray Narrow Trial Caddy
• 10889981162733: Regatta Instrument Tray Case
• 10889981162726: Regatta Instrument Tray Level Bottom
• 10889981162719: Regatta Instrument Tray Level Top
• 10889981162702: Regatta Instrument Tray
• 10889981162665: Lateral Paddle Shaver, 6mm
• 10889981162658: Lateral Paddle Shaver, 4mm
• 10889981162641: Lateral Box Cutter, 6x23mm, Angled
• 10889981162634: Lateral Box Cutter, 4x23mm, Angled
• 10889981162627: Lateral Box Cutter, 4x18mm, Angled
• 10889981162610: Lateral Box Cutter, 6x18mm
• 10889981162603: Lateral Box Cutter, 4x18mm, Angled