Vu a-POD™ 21-LT-3116

GUDID 10889981038465

31x24mm Implant 16mm 12 deg

SEASPINE ORTHOPEDICS CORPORATION

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 10889981038465
• NIH Device Record Key: 10c7443c-8fa8-4c5a-a543-e867862fe1e6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vu a-POD™
• Version Model Number: 21-LT-3116
• Catalog Number: 21-LT-3116
• 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 Dimensions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10889981038465 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080822

FDA Product Code

• OVD: Intervertebral fusion device with integrated fixation, lumbar

Sterilization

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

[10889981038465]

Moist Heat or Steam Sterilization

[10889981038465]

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: 2015-09-24

On-Brand Devices [Vu a-POD™]

• 10889981062330: Vu aPOD Prime Anterior IBF Implants
• 10889981062323: Vu aPOD Prime Anterior IBF Implants
• 10889981042301: 45 Degree Offset Inserter
• 10889981042295: Starter Trial
• 10889981042288: 90 Degree Lateral Inserter
• 10889981042271: 45 Degree Offset Inserter
• 10889981042264: 15 Degree Offset Inserter
• 10889981042257: Anterior Inserter
• 10889981042240: 39x30mm Trial Rasp 16mm 15 deg
• 10889981042233: 39x30mm Trial Rasp 14mm 15 deg
• 10889981042226: 39x30mm Trial Rasp 12mm 15 deg
• 10889981042219: 35x27mm Trial Rasp 16mm 15 deg
• 10889981042202: 35x27mm Trial Rasp 14mm 15 deg
• 10889981042196: 35x27mm Trial Rasp 12mm 15 deg
• 10889981042189: 31x24mm Trial Rasp 16mm 15 deg
• 10889981042172: 31x24mm Trial Rasp 14mm 15 deg
• 10889981042165: 31x24mm Trial Rasp 12mm 15 deg
• 10889981042158: 39x30mm Trial Rasp 16mm 12 deg
• 10889981042141: 39x30mm Trial Rasp 14mm 12 deg
• 10889981042134: 39x30mm Trial Rasp 12mm 12 deg
• 10889981042127: 39x30mm Trial Rasp 10mm 12 deg
• 10889981042110: 39x30mm Trial Rasp 8mm 12 deg
• 10889981042103: 35x27mm Trial Rasp 16mm 12 deg
• 10889981042097: 35x27mm Trial Rasp 14mm 12 deg
• 10889981042080: 35x27mm Trial Rasp 12mm 12 deg
• 10889981042073: 35x27mm Trial Rasp 10mm 12 deg
• 10889981042066: 35x27mm Trial Rasp 8mm 12 deg
• 10889981042059: 31x24mm Trial Rasp 16mm 12 deg
• 10889981042042: 31x24mm Trial Rasp 14mm 12 deg
• 10889981042035: 31x24mm Trial Rasp 12mm 12 deg
• 10889981042028: 31x24mm Trial Rasp 10mm 12 deg
• 10889981042011: 31x24mm Trial Rasp 8mm 12 deg
• 10889981042004: 27x21mm Trial Rasp 16mm 12 deg
• 10889981041991: 27x21mm Trial Rasp 14mm 12 deg
• 10889981041984: 27x21mm Trial Rasp 12mm 12 deg
• 10889981041977: 27x21mm Trial Rasp 10mm 12 deg
• 10889981041960: 27x21mm Trial Rasp 8mm 12 deg
• 10889981041953: 39x30mm Trial Rasp 16mm 8 deg
• 10889981041946: 39x30mm Trial Rasp 14mm 8 deg
• 10889981041939: 39x30mm Trial Rasp 12mm 8 deg
• 10889981041922: 39x30mm Trial Rasp 10mm 8 deg
• 10889981041915: 39x30mm Trial Rasp 8mm 8 deg
• 10889981041908: 35x27mm Trial Rasp 16mm 8 deg
• 10889981041892: 35x27mm Trial Rasp 14mm 8 deg
• 10889981041885: 35x27mm Trial Rasp 12mm 8 deg
• 10889981041878: 35x27mm Trial Rasp 10mm 8 deg
• 10889981041861: 35x27mm Trial Rasp 8mm 8 deg
• 10889981041854: 31x24mm Trial Rasp 16mm 8 deg
• 10889981041847: 31x24mm Trial Rasp 14mm 8 deg
• 10889981041830: 31x24mm Trial Rasp 12mm 8 deg