Vu LPOD™ IBF 12-TA-2616

GUDID 10889981108601

Implant Tapered 26x16mm

SEASPINE ORTHOPEDICS CORPORATION

Vertebral body prosthesis, non-sterile

• Primary Device ID: 10889981108601
• NIH Device Record Key: 0b33492b-140c-40da-923f-97bbeaa9cffe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vu LPOD™ IBF
• Version Model Number: 12-TA-2616
• Catalog Number: 12-TA-2616
• 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: 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	10889981108601 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082712

FDA Product Code

• MQP: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Sterilization

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

[10889981108601]

Moist Heat or Steam Sterilization

[10889981108601]

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: 2016-04-29

On-Brand Devices [Vu LPOD™ IBF]

• 10889981108601: Implant Tapered 26x16mm
• 10889981108595: Implant Tapered 26x15mm
• 10889981108588: Implant Tapered 26x14mm
• 10889981108571: Implant Tapered 26x13mm
• 10889981108557: Implant Tapered 26x11mm
• 10889981108540: Implant Tapered 26x10mm
• 10889981108526: Implant Tapered 26x8mm
• 10889981108519: Implant Tapered 22x16mm
• 10889981108502: Implant Tapered 22x15mm
• 10889981108496: Implant Tapered 22x14mm
• 10889981108489: Implant Tapered 22x13mm
• 10889981108472: Implant Tapered 22x12mm
• 10889981108458: Implant Tapered 22x10mm
• 10889981108441: Implant Tapered 22x9mm
• 10889981108434: Implant Tapered 22x8mm
• 10889981108311: Implant Non-Tapered 30x16mm
• 10889981108304: Implant Non-Tapered 30x15mm
• 10889981108298: Implant Non-Tapered 30x14mm
• 10889981108281: Implant Non-Tapered 30x13mm
• 10889981108274: Implant Non-Tapered 30x12mm
• 10889981108267: Implant Non-Tapered 30x11mm
• 10889981108250: Implant Non-Tapered 30x10mm
• 10889981108243: Implant Non-Tapered 30x9mm
• 10889981108236: Implant Non-Tapered 30x8mm
• 10889981108229: Implant Non-Tapered 30x7mm
• 10889981108113: Implant Non-Tapered 26x16mm
• 10889981108106: Implant Non-Tapered 26x15mm
• 10889981108090: Implant Non-Tapered 26x14mm
• 10889981108083: Implant Non-Tapered 26x13mm
• 10889981108076: Implant Non-Tapered 26x12mm
• 10889981108069: Implant Non-Tapered 26x11mm
• 10889981108052: Implant Non-Tapered 26x10mm
• 10889981108045: Implant Non-Tapered 26x9mm
• 10889981108038: Implant Non-Tapered 26x8mm
• 10889981108021: Implant Non-Tapered 26x7mm
• 10889981107918: Implant Non-Tapered 22x16mm
• 10889981107901: Implant Non-Tapered 22x15mm
• 10889981107895: Implant Non-Tapered 22x14mm
• 10889981107888: Implant Non-Tapered 22x13mm
• 10889981107871: Implant Non-Tapered 22x12mm
• 10889981107864: Implant Non-Tapered 22x11mm
• 10889981107857: Implant Non-Tapered 22x10mm
• 10889981107840: Implant Non-Tapered 22x9mm
• 10889981107833: Implant Non-Tapered 22x8mm
• 10889981107826: Implant Non-Tapered 22x7mm