SeaSpine Expandable Interbody 82-2608

GUDID 10889981123499

IMPLANT, 26mm LG, 8-12mm HT, 10mm WD, 0 DEG

SEASPINE ORTHOPEDICS CORPORATION

Vertebral body prosthesis, non-sterile

• Primary Device ID: 10889981123499
• NIH Device Record Key: fda7ff3b-9876-49fa-8b5b-bfc2ee7d33e9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SeaSpine Expandable Interbody
• Version Model Number: 82-2608
• Catalog Number: 82-2608
• 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: true
• 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	10889981123499 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133418

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

Sterilization

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

[10889981123499]

Moist Heat or Steam Sterilization

[10889981123499]

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: 2017-05-12

On-Brand Devices [SeaSpine Expandable Interbody]

• 10889981123864: 30mm Implant Caddy
• 10889981123857: 26mm Implant Caddy
• 10889981123840: 22mm Implant Caddy
• 10889981123833: Implant Tray
• 10889981123826: Instrument Tray
• 10889981123819: Guide Hex Rod
• 10889981123802: Bone Funnel
• 10889981123796: Driver
• 10889981123789: 18mm Trial (22x10mm, 0 deg)
• 10889981123772: 17mm Trial (22x10mm, 0 deg)
• 10889981123765: 16mm Trial (22x10mm, 0 deg)
• 10889981123758: 15mm Trial (22x10mm, 0 deg)
• 10889981123741: 14mm Trial (22x10mm, 0 deg)
• 10889981123734: 13mm Trial (22x10mm, 0 deg)
• 10889981123727: 12mm Trial (22x10mm, 0 deg)
• 10889981123710: 11mm Trial (22x10mm, 0 deg)
• 10889981123703: 10mm Trial (22x10mm, 0 deg)
• 10889981123697: 9mm Trial (22x10mm, 0 deg)
• 10889981123680: 8mm Trial (22x10mm, 0 deg)
• 10889981123673: 6mm Starter Trial
• 10889981123666: 12mm Wide Removal Tool
• 10889981123659: Removal Tool
• 10889981123642: Expansion Driver
• 10889981123635: Expansion Driver
• 10889981123628: Inserter
• 10889981123611: Inserter
• 10889981123604: IMPLANT, 30mm LG, 12-18mm HT, 12mm WD, 0 DEG
• 10889981123598: IMPLANT, 30mm LG, 10-15mm HT, 12mm WD, 0 DEG
• 10889981123581: IMPLANT, 30mm LG, 8-12mm HT, 12mm WD, 0 DEG
• 10889981123574: IMPLANT, 30mm LG, 12-18mm HT, 10mm WD, 0 DEG
• 10889981123567: IMPLANT, 30mm LG, 10-15mm HT, 10mm WD, 0 DEG
• 10889981123550: IMPLANT, 30mm LG, 8-12mm HT, 10mm WD, 0 DEG
• 10889981123543: IMPLANT, 26mm LG, 12-18mm HT, 12mm WD, 0 DEG
• 10889981123536: IMPLANT, 26mm LG, 10-15mm HT, 12mm WD, 0 DEG
• 10889981123529: IMPLANT, 26mm LG, 8-12mm HT, 12mm WD, 0 DEG
• 10889981123512: IMPLANT, 26mm LG, 12-18mm HT, 10mm WD, 0 DEG
• 10889981123505: IMPLANT, 26mm LG, 10-15mm HT, 10mm WD, 0 DEG
• 10889981123499: IMPLANT, 26mm LG, 8-12mm HT, 10mm WD, 0 DEG
• 10889981123482: IMPLANT, 22mm LG, 10-15mm HT, 12mm WD, 0 DEG
• 10889981123475: IMPLANT, 22mm LG, 10-15mm HT, 12mm WD, 0 DEG
• 10889981123468: IMPLANT, 22mm LG, 8-12mm HT, 12mm WD, 0 DEG
• 10889981123451: IMPLANT, 22mm LG, 12-18mm HT, 10mm WD, 0 DEG
• 10889981123444: IMPLANT, 22mm LG, 10-15mm HT, 10mm WD, 0 DEG
• 10889981123437: IMPLANT, 22mm LG, 8-12mm HT, 10mm WD, 0 DEG
• 10889981123420: Expandable IBD Implants
• 10889981120764: Inserter