Vu a-POD Prime 33-14-6020

GUDID 10889981140052

ALIF Implant Locking Screw 6.0mm X 20mm

SEASPINE ORTHOPEDICS CORPORATION

Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 10889981140052
• NIH Device Record Key: 2536014e-29f4-47ce-839a-3eac9c3b8a9d
• Commercial Distribution Discontinuation: 2017-05-07
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Vu a-POD Prime
• Version Model Number: 33-14-6020
• Catalog Number: 33-14-6020
• 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
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10889981140052 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101310

FDA Product Code

• OVD: Intervertebral fusion device with integrated fixation, lumbar

Sterilization

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

[10889981140052]

Moist Heat or Steam Sterilization

[10889981140052]

Moist Heat or Steam Sterilization

[10889981140052]

Moist Heat or Steam Sterilization

[10889981140052]

Moist Heat or Steam Sterilization

[10889981140052]

Moist Heat or Steam Sterilization

[10889981140052]

Moist Heat or Steam Sterilization

[10889981140052]

Moist Heat or Steam Sterilization

[10889981140052]

Moist Heat or Steam Sterilization

[10889981140052]

Moist Heat or Steam Sterilization

[10889981140052]

Moist Heat or Steam Sterilization

[10889981140052]

Moist Heat or Steam Sterilization

[10889981140052]

Moist Heat or Steam Sterilization

[10889981140052]

Moist Heat or Steam Sterilization

[10889981140052]

Moist Heat or Steam Sterilization

[10889981140052]

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: 2017-01-18

On-Brand Devices [Vu a-POD Prime]

• 10889981140052: ALIF Implant Locking Screw 6.0mm X 20mm
• 10889981136253: VU APOD ANTERIOR IBF IMPLANTS / INSTRUMENTS
• 10889981121532: Bone Screw Caddy
• 10889981121525: Anterior Inserter
• 10889981118617: Vu aPOD Prime 35x27 LT Implant Caddy
• 10889981118600: Vu aPOD Prime 35x27 TA Implant Caddy
• 10889981118594: Vu aPOD Prime 31x24 LT Implant Caddy
• 10889981118587: Vu aPOD Prime 31x24 TA Implant Caddy
• 10889981118570: Implant Tray
• 10889981118556: Instrument Tray
• 10889981118549: Vu Trak
• 10889981118532: Quick Release Inserter Assembly
• 10889981118525: DRILL GUIDE ASSEMBLY, 18mm
• 10889981118518: Drill Guide Assembly 16mm
• 10889981118501: Drill Guide Assembly 14mm
• 10889981118495: Drill Guide Assembly 12mm
• 10889981118488: Drill Guide Assembly 10mm
• 10889981118464: Instrument Back Table Driver
• 10889981118457: Flexible Shaft Driver
• 10889981118440: U-Joint Driver Assembly, Self-Retain
• 10889981118433: Fixed Driver Assembly, Self Retain
• 10889981118426: Screw Extractor Assembly
• 10889981118419: U-Joint Driver Assembly, Self Centering
• 10889981118402: Fixed Driver Assembly, Self Centering
• 10889981118396: Flexible Shaft Drill
• 10889981118389: U-Joint Drill Assembly
• 10889981118372: Fixed Drill Assembly
• 10889981118365: U-Joint Drill Assembly, Self Centering
• 10889981118358: Fixed Drill Assembly, Self Centering
• 10889981118341: U-Joint Awl Assembly
• 10889981118297: Fixed Awl Assembly
• 10889981118280: U-Joint Awl Assembly, Self Centering
• 10889981118273: Fixed Awl Assembly, Self Centering
• 10889981118266: Handheld Guide
• 10889981107734: Wrench
• 10889981102470: Slap Hammer