Regatta 36-181255-00

GUDID 10889981158385

Lateral Implant, 18mm x 12mm x 55mm, 0 Deg

SEASPINE ORTHOPEDICS CORPORATION

Vertebral body prosthesis

• Primary Device ID: 10889981158385
• NIH Device Record Key: 9e8530cb-5d59-4daa-af62-1ca1c57c4642
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Regatta
• Version Model Number: 36-181255-00
• Catalog Number: 36-181255-00
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10889981158385 [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: 2019-07-26

On-Brand Devices [Regatta]

• 10889981170868: Lateral Disc Prep Set
• 10889981158736: Lateral Implant, 18mm x 16mm x 60mm, 15 Deg
• 10889981158729: Lateral Implant, 18mm x 16mm x 60mm, 10 Deg
• 10889981158712: Lateral Implant, 18mm x 16mm x 60mm, 0 Deg
• 10889981158699: Lateral Implant, 18mm x 16mm x 55mm, 10 Deg
• 10889981158682: Lateral Implant, 18mm x 16mm x 55mm, 0 Deg
• 10889981158668: Lateral Implant, 18mm x 16mm x 50mm, 10 Deg
• 10889981158651: Lateral Implant, 18mm x 16mm x 50mm, 0 Deg
• 10889981158637: Lateral Implant, 18mm x 16mm x 45mm, 10 Deg
• 10889981158620: Lateral Implant, 18mm x 16mm x 45mm,0 Deg
• 10889981158606: Lateral Implant, 18mm x 16mm x 40mm, 10 Deg
• 10889981158590: Lateral Implant, 18mm x 16mm x 40mm,0 Deg
• 10889981158583: Lateral Implant, 18mm x 14mm x 60mm, 15 Deg
• 10889981158576: Lateral Implant, 18mm x 14mm x 60mm, 10 Deg
• 10889981158569: Lateral Implant, 18mm x 14mm x 60mm, 0 Deg
• 10889981158538: Lateral Implant, 18mm x 14mm x 55mm, 0 Deg
• 10889981158460: Lateral Implant, 18mm x 14mm x 40mm, 15 Deg
• 10889981158415: Lateral Implant, 18mm x 12mm x 60mm, 0 Deg
• 10889981158385: Lateral Implant, 18mm x 12mm x 55mm, 0 Deg
• 10889981158316: Lateral Implant, 18mm x 12mm x 40mm, 15 Deg
• 10889981158262: Lateral Implant, 18mm x 10mm x 60mm, 0 Deg
• 10889981158231: Lateral Implant, 18mm x 10mm x 55mm, 0 Deg
• 10889981158163: Lateral Implant, 18mm x 10mm x 40mm, 15 Deg
• 10889981158125: Lateral Implant, 18mm x 8mm x 60mm, 0 Deg
• 10889981158101: Lateral Implant, 18mm x 8mm x 55mm, 0 Deg
• 10889981231330: Screw Caddy
• 10889981231323: 2 & 4 Hole Plate Caddy
• 10889981231316: Regatta Plate Tray Level 2
• 10889981231309: Regatta Plate Tray Level 1
• 10889981231293: Regatta Plate Case
• 10889981231279: 1 Hole Plate Screw Caddy
• 10889981231262: 1 Hole Plate Caddy
• 10889981231255: Regatta 1 Hole Plate Tray Level 1
• 10889981231248: Regatta 1 Hole Plate Case
• 10889981231224: Modular Assembly Tip, Interbody
• 10889981231217: Modular Assembly Tip, Plate
• 10889981231200: Straight Drill Variable
• 10889981231194: Straight Awl Variable
• 10889981231187: TruProfile Lateral Inserter
• 10889981231170: 4 Hole Lateral Plate, 20mm
• 10889981231163: 4 Hole Lateral Plate, 18mm
• 10889981231156: 4 Hole Lateral Plate, 16mm
• 10889981231149: 4 Hole Lateral Plate, 14mm
• 10889981231132: 4 Hole Lateral Plate, 12mm
• 10889981231125: 4 Hole Lateral Plate, 10mm
• 10889981231118: 4 Hole Lateral Plate, 8mm
• 10889981231101: 2 Hole Lateral Plate, 20mm
• 10889981231095: 2 Hole Lateral Plate, 18mm
• 10889981231088: 2 Hole Lateral Plate, 16mm
• 10889981231071: 2 Hole Lateral Plate, 14mm