Vu aPod™ - L 31-10-0840

GUDID 10889981045876

LATERAL IMPLANT, STANDARD SPINPLATE™, 8mm X 40mm

SEASPINE ORTHOPEDICS CORPORATION

Vertebral body prosthesis, non-sterile

• Primary Device ID: 10889981045876
• NIH Device Record Key: 70760d68-3d35-404d-8e6d-467f3b772ff8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vu aPod™ - L
• Version Model Number: 31-10-0840
• Catalog Number: 31-10-0840
• 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	10889981045876 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112986

FDA Product Code

• OVD: Intervertebral fusion device with integrated fixation, lumbar

Sterilization

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

[10889981045876]

Moist Heat or Steam Sterilization

[10889981045876]

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 aPod™ - L]

• 10889981121501: Trial Extractor, 8mm Lordotic
• 10889981121495: Angled Draw Rod Assembly, 6-32, 8mm Lordotic
• 10889981121488: SPINPLATE Snap Assist Tool
• 10889981121471: Graft Block
• 10889981118150: Vu aPod-L Instrument Case
• 10889981118143: Lordotic Wide Implant Caddy, 60mm
• 10889981118136: Wide Lordotic Implant Caddy, 55mm
• 10889981118129: Wide Lordotic Implant Caddy, 50mm
• 10889981118112: Wide Lordotic Implant Caddy, 45mm
• 10889981118105: Wide Lordotic Implant Caddy, 40mm
• 10889981118099: Wide Standard Implant Caddy, 60mm
• 10889981118082: Wide Standard Implant Caddy, 55mm
• 10889981118075: Wide Standard Implant Caddy, 50mm
• 10889981118068: Wide Standard Implant Caddy, 45mm
• 10889981118051: Wide Standard Implant Caddy, 40mm
• 10889981118044: Vu aPod-L Wide Implant Case
• 10889981118037: Narrow Lordotic Implant Caddy, 60mm
• 10889981118020: Narrow Lordotic Implant Caddy, 55mm
• 10889981118013: Narrow Lordotic Implant Caddy, 50mm
• 10889981118006: Narrow Lordotic Implant Caddy, 45mm
• 10889981117993: Narrow Lordotic Implant Caddy, 40mm
• 10889981117986: Narrow Standard Implant Caddy, 60mm
• 10889981117979: Narrow Standard Implant Caddy, 55mm
• 10889981117962: Narrow Standard Implant Caddy, 50mm
• 10889981117955: Narrow Standard Implant Caddy, 45mm
• 10889981117948: Narrow Standard Implant Caddy, 40mm
• 10889981117931: Vu aPod-L Narrow Implant Case
• 10889981117924: Trial Extractor, Standard
• 10889981117917: Angled Draw Rod Assembly, 12-28, Standard
• 10889981117900: Angled Lateral Inserter Housing, RH
• 10889981117894: Angled Lateral Inserter Housing, LH
• 10889981117887: SPINPLATE Locker
• 10889981117870: Lateral implant insertion slide
• 10889981117863: Implant Slides
• 10889981097776: Graft Tamp
• 10889981097738: Slotted Mallet, .255
• 10889981097721: Hudson Silicone Handle
• 10889981062422: Vu aPod-L W Implant
• 10889981062415: Vu aPod-L Narrow Implant
• 10889981062408: Vu-aPOD-L 60mm Wide Optional Implant Caddy
• 10889981062392: Vu-aPOD-L 60mm Narrow Optional Implant Caddy
• 10889981062385: Vu-aPOD-L 45mm Wide Optional Implant Caddy
• 10889981062378: Vu-aPOD-L 45mm Narrow Optional Implant Caddy
• 10889981062361: Vu-aPOD-L 40mm Narrow Optional Implant Caddy
• 10889981062354: Vu aPOD-L instrument
• 10889981062347: Vu-aPOD-L 50 mm-55 mm Wide w-SpinPlate Implant Cad
• 10889981048167: LATERAL TRIAL, NARROW, LORDOTIC, 8mm X 18mm X 60mm X 10°
• 10889981048150: LATERAL TRIAL, NARROW, LORDOTIC, 8mm X 18mm X 55mm X 10°
• 10889981048143: LATERAL TRIAL, NARROW, LORDOTIC, 8mm X 18mm X 50mm X 10°
• 10889981048136: LATERAL TRIAL, NARROW, LORDOTIC, 8mm X 18mm X 45mm X 10°