Vu a-POD Prime NanoMetalene 35-30-1820

GUDID 10889981139544

Prime NM Implant, 43x30mm x 18mm 20 Deg

SEASPINE ORTHOPEDICS CORPORATION

Vertebral body prosthesis

• Primary Device ID: 10889981139544
• NIH Device Record Key: 1dec3a43-9f24-452b-8fcc-019abc62d2ba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vu a-POD Prime NanoMetalene
• Version Model Number: 35-30-1820
• Catalog Number: 35-30-1820
• 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	10889981139544 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162351

FDA Product Code

• OVD: Intervertebral fusion device with integrated fixation, lumbar

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-24
• Device Publish Date: 2016-12-06

On-Brand Devices [Vu a-POD Prime NanoMetalene]

• 10889981141097: Implant Tray, Case
• 10889981141080: Implant Tray, Lower Tray
• 10889981141073: Implant Tray, Upper Tray
• 10889981140069: Locking Screw Snap Ring
• 10889981140045: Vu aPOD Prime NM Tray Lid
• 10889981139568: Prime NM Implant, 43x30mm x 20mm 30 Deg
• 10889981139551: Prime NM Implant, 43x30mm x 18mm 30 Deg
• 10889981139544: Prime NM Implant, 43x30mm x 18mm 20 Deg
• 10889981139537: Prime NM Implant, 43x30mm x 16mm 20 Deg
• 10889981139520: Prime NM Implant, 43x30mm x 14mm 20 Deg
• 10889981139513: Prime NM Implant, 39x27mm x 20mm, 30 Deg
• 10889981139506: Prime NM Implant, 39x27mm x 18mm, 30 Deg
• 10889981139490: Prime NM Implant, 39x27mm x 18mm, 20 Deg
• 10889981139483: Prime NM Implant, 39x27mm x 16mm, 20 Deg
• 10889981139476: Prime NM Implant, 39x27mm x 14mm, 20 Deg
• 10889981139469: Prime NM Implant, 43x30mm x 16mm 15 Deg
• 10889981139452: Prime NM Implant, 43x30mm x 14mm 15 Deg
• 10889981139445: Prime NM Implant, 43x30mm x 12mm 15 Deg
• 10889981139438: Prime NM Implant, 43x30mm x 16mm 10 Deg
• 10889981139421: Prime NM Implant, 43x30mm x 14mm 10 Deg
• 10889981139414: Prime NM Implant, 43x30mm x 12mm 10 Deg
• 10889981139407: Prime NM Implant, 43x30mm x 10mm 10 Deg
• 10889981139391: Prime NM Implant, 39x27mm x 16mm, 15 Deg
• 10889981139384: Prime NM Implant, 39x27mm x 14mm, 15 Deg
• 10889981139377: Prime NM Implant, 39x27mm x 12mm, 15 Deg
• 10889981139360: Prime NM Implant, 39x27mm x 16mm, 10 Deg
• 10889981139353: Prime NM Implant, 39x27mm x 14mm, 10 Deg
• 10889981139346: Prime NM Implant, 39x27mm x 12mm, 10 Deg
• 10889981139339: Prime NM Implant, 39x27mm x 10mm, 10 Deg
• 10889981139322: Vu aPOD Prime NM Tray Lid
• 10889981139315: Vu aPOD Prime NM Implant Trial Caddy
• 10889981139308: Vu aPOD Prime NM Bone Screw Caddy
• 10889981139292: Vu aPOD Prime NM Spin Plate Caddy
• 10889981139285: Vu aPOD Prime NM Implant Case - Level 1
• 10889981139278: Vu aPOD Prime NM Implant Case
• 10889981139261: Vu aPOD Prime NM 20 and 30 Deg. Hyper Trial Caddy
• 10889981139254: Vu aPOD Prime NM Instrument Case - Level 2
• 10889981139247: Vu aPOD Prime NM Instrument Case - Level 1
• 10889981139230: Vu aPOD Prime NM Instrument Case
• 10889981138486: Prime NM Locking Screw, 6.5 Dia. X 35mm
• 10889981138479: Prime NM Locking Screw, 6.5 Dia. X 27mm
• 10889981138462: Prime NM Locking Screw, 6.0 Dia. X 35mm
• 10889981138455: Prime NM Locking Screw, 6.0 Dia. X 27mm
• 10889981138448: Prime NM Locking Screw, 5.5 Dia. X 35mm
• 10889981138431: Prime NM Locking Screw, 5.5 Dia. X 30mm
• 10889981138424: Prime NM Locking Screw, 5.5 Dia. X 27mm
• 10889981138417: Prime NM Locking Screw, 5.5 Dia. X 25mm
• 10889981138400: Prime NM Locking Screw, 5.5 Dia. X 20mm
• 10889981138127: 43X30MM Trial 16mm 25DEG
• 10889981138110: 43X30MM Trial 14mm 25DEG