Vu a-POD Prime™ 33-LT-3518

GUDID 10889981061128

35x27mm Implant 18mm 12 deg

SEASPINE ORTHOPEDICS CORPORATION

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 10889981061128
• NIH Device Record Key: e60b184d-68d2-4588-9d1e-2b50da8fe097
• Commercial Distribution Discontinuation: 2016-09-02
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Vu a-POD Prime™
• Version Model Number: 33-LT-3518
• Catalog Number: 33-LT-3518
• 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(866)942-8698
• Email: custsvcspine@seaspine.com
• Phone: +1(866)942-8698
• Email: custsvcspine@seaspine.com
• Phone: +1(866)942-8698
• Email: custsvcspine@seaspine.com
• Phone: +1(866)942-8698
• Email: custsvcspine@seaspine.com
• Phone: +1(866)942-8698
• Email: custsvcspine@seaspine.com
• Phone: +1(866)942-8698
• Email: custsvcspine@seaspine.com
• Phone: +1(866)942-8698
• Email: custsvcspine@seaspine.com
• Phone: +1(866)942-8698
• Email: custsvcspine@seaspine.com
• Phone: +1(866)942-8698
• Email: custsvcspine@seaspine.com
• Phone: +1(866)942-8698
• Email: custsvcspine@seaspine.com
• Phone: +1(866)942-8698
• Email: custsvcspine@seaspine.com
• Phone: +1(866)942-8698
• Email: custsvcspine@seaspine.com
• Phone: +1(866)942-8698
• Email: custsvcspine@seaspine.com
• Phone: +1(866)942-8698
• Email: custsvcspine@seaspine.com
• Phone: +1(866)942-8698
• Email: custsvcspine@seaspine.com
• Phone: +1(866)942-8698
• Email: custsvcspine@seaspine.com
• Phone: +1(866)942-8698
• Email: custsvcspine@seaspine.com
• Phone: +1(866)942-8698
• Email: custsvcspine@seaspine.com
• Phone: +1(866)942-8698
• Email: custsvcspine@seaspine.com
• Phone: +1(866)942-8698
• Email: custsvcspine@seaspine.com
• Phone: +1(866)942-8698
• Email: custsvcspine@seaspine.com
• Phone: +1(866)942-8698
• Email: custsvcspine@seaspine.com
• Phone: +1(866)942-8698
• Email: custsvcspine@seaspine.com
• Phone: +1(866)942-8698
• Email: custsvcspine@seaspine.com
• Phone: +1(866)942-8698
• Email: custsvcspine@seaspine.com
• Phone: +1(866)942-8698
• Email: custsvcspine@seaspine.com
• Phone: +1(866)942-8698
• Email: custsvcspine@seaspine.com
• Phone: +1(866)942-8698
• Email: custsvcspine@seaspine.com
• Phone: +1(866)942-8698
• Email: custsvcspine@seaspine.com

Device Dimensions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10889981061128 [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

[10889981061128]

Moist Heat or Steam Sterilization

[10889981061128]

Moist Heat or Steam Sterilization

[10889981061128]

Moist Heat or Steam Sterilization

[10889981061128]

Moist Heat or Steam Sterilization

[10889981061128]

Moist Heat or Steam Sterilization

[10889981061128]

Moist Heat or Steam Sterilization

[10889981061128]

Moist Heat or Steam Sterilization

[10889981061128]

Moist Heat or Steam Sterilization

[10889981061128]

Moist Heat or Steam Sterilization

[10889981061128]

Moist Heat or Steam Sterilization

[10889981061128]

Moist Heat or Steam Sterilization

[10889981061128]

Moist Heat or Steam Sterilization

[10889981061128]

Moist Heat or Steam Sterilization

[10889981061128]

Moist Heat or Steam Sterilization

[10889981061128]

Moist Heat or Steam Sterilization

[10889981061128]

Moist Heat or Steam Sterilization

[10889981061128]

Moist Heat or Steam Sterilization

[10889981061128]

Moist Heat or Steam Sterilization

[10889981061128]

Moist Heat or Steam Sterilization

[10889981061128]

Moist Heat or Steam Sterilization

[10889981061128]

Moist Heat or Steam Sterilization

[10889981061128]

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 Prime™]

• 10889981061258: 39x30mm Implant 18mm 8 deg.
• 10889981061241: 35x27mm Implant 18mm 15 deg.
• 10889981061234: 39x30mm Implant 18mm 15 Deg.
• 10889981061227: Locking Screw 6.5x35mm
• 10889981061210: Locking Screw 6.5x30mm
• 10889981061203: Locking Screw 6.5x25mm
• 10889981061197: Locking Screw 6.5x20mm
• 10889981061180: Locking Screw 5.5x35mm
• 10889981061173: Locking Screw 5.5x30mm
• 10889981061166: Locking Screw 5.5x25mm
• 10889981061159: Locking Screw 5.5x20mm
• 10889981061142: 35x27mm Implant 18mm 8 deg
• 10889981061135: 31x24mm Implant 18mm 8 deg
• 10889981061128: 35x27mm Implant 18mm 12 deg
• 10889981061111: 31x24mm Implant 18mm 12 deg
• 10889981061104: 39x30 Implant 16mm 15 Deg
• 10889981061098: 39x30 Implant 14mm 15 Deg
• 10889981061081: 39x30 Implant 12mm 15 Deg
• 10889981061074: 39x30 Implant 10mm 15 Deg
• 10889981061067: 35x27mm Implant 16mm 15 DEG
• 10889981061050: 35x27mm Implant 14mm 15 DEG
• 10889981061043: 35x27mm Implant 12mm 15 DEG
• 10889981061036: 35x27mm Implant 10mm 15 DEG
• 10889981061029: 31x24mm Implant 18mm 15 Deg
• 10889981061012: 31x24mm Implant 16mm 15 Deg
• 10889981061005: 31x24mm Implant 14mm 15 Deg
• 10889981060992: 31x24mm Implant 12mm 15 Deg
• 10889981060985: 31x24mm Implant 10mm 15 Deg
• 10889981060978: 39x27mm Implant 16mm 8 DEG
• 10889981060961: 39x27mm Implant 14mm 8 DEG
• 10889981060954: 39x27mm Implant 12mm 8 DEG
• 10889981060947: 39x27mm Implant 10mm 8 DEG
• 10889981060930: 35x27mm Implant 16mm 8 DEG
• 10889981060923: 35x27mm Implant 14mm 8 DEG
• 10889981060916: 35x27mm Implant 12mm 8 DEG
• 10889981060909: 35x27mm Implant 10mm 8 DEG
• 10889981060893: 31x24mm Implant 16mm 8 Deg
• 10889981060886: 31x24mm Implant 14mm 8 Deg
• 10889981060879: 31x24mm Implant 12mm 8 Deg
• 10889981060862: 31x24mm Implant 10mm 8 Deg
• 10889981060855: 39x27mm Implant 16mm 12 DEG
• 10889981060848: 39x27mm Implant 14mm 12 DEG
• 10889981060831: 39x27mm Implant 12mm 12 DEG
• 10889981060824: 39x27mm Implant 10mm 12 DEG
• 10889981060817: 35x27mm Implant 16mm 12 DEG
• 10889981060800: 35x27mm Implant 14mm 12 DEG
• 10889981060794: 35x27mm Implant 12mm 12 DEG
• 10889981060787: 35x27mm Implant 10mm 12 DEG
• 10889981060770: 31x24mm Implant 16mm 12 Deg
• 10889981060763: 31x24mm Implant 14mm 12 Deg