Virata TL1-30250040

GUDID 10889981337650

Shank, CC, 5.0mm X 40mm

Seaspine Orthopedics Corporation

Spinal bone screw, non-bioabsorbable

• Primary Device ID: 10889981337650
• NIH Device Record Key: a0976b18-b3d7-4b02-824f-8fe7f8c2a6f5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Virata
• Version Model Number: TL1-30250040
• Catalog Number: TL1-30250040
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10889981337650 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K250908

FDA Product Code

• NKB: Thoracolumbosacral pedicle screw system

Sterilization

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

[10889981337650]

Moist Heat or Steam Sterilization

[10889981337650]

Moist Heat or Steam Sterilization

[10889981337650]

Moist Heat or Steam Sterilization

[10889981337650]

Moist Heat or Steam Sterilization

[10889981337650]

Moist Heat or Steam Sterilization

[10889981337650]

Moist Heat or Steam Sterilization

[10889981337650]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-10-06
• Device Publish Date: 2025-09-26

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• 10889981439231: Guidewire, Nitinol, Trochar, 400mm
• 10889981439224: Guidewire, Nitinol, Trochar, 300mm
• 10889981387822: Rod Manipulation Tray, Level 3
• 10889981387808: Tray Lid, Universal
• 10889981387792: Navigation Tray Case
• 10889981387785: Navigation INST Tray, Level 1
• 10889981387778: Navigation INST Tray, Level 2
• 10889981387761: Set Screw Caddy
• 10889981387754: Set Screw Caddy Lid
• 10889981387747: Modular Tulip Caddy
• 10889981387730: Modular Tulip Caddy Lid
• 10889981387723: Ø5.5mm Shank Caddy
• 10889981387716: Modular Shank Caddy Lid
• 10889981387709: Ø6.5mm Shank Caddy
• 10889981387693: Modular Tulip Caddy Lid
• 10889981387686: Ø7.5mm Shank Caddy
• 10889981387679: Ø8.5mm Shank Caddy
• 10889981387631: Preassembled Screw Caddy
• 10889981387624: Preassembled Screw Caddy Lid
• 10889981387617: Ø5.5mm Rod Caddy
• 10889981387600: Rod Caddy Lid
• 10889981387594: Solid IMP Tray Case
• 10889981387587: Solid IMP Tray, Level 1
• 10889981387570: Solid IMP Tray, Level 2
• 10889981387563: Cannulated IMP Tray Case
• 10889981387556: Cannulated IMP Tray Insert, Level 1
• 10889981387549: Cannulated IMP Tray, Level 2
• 10889981387532: Solid INST Tray Case
• 10889981387525: Solid INST Tray, Level 1
• 10889981387518: Solid INST Tray, Level 2
• 10889981387501: Solid INST Tray, Level 3
• 10889981387495: Cannulated INST Tray Case
• 10889981387488: Cannulated INST Tray, Level 1
• 10889981387471: Cannulated INST Tray, Level 2
• 10889981387464: Cannulated INST Tray, Level 3
• 10889981387457: Rod Manipulation Tray Case
• 10889981387440: Rod Manipulation Tray, Level 1
• 10889981387433: Rod Manipulation Tray, Level 2
• 10889981387426: Long Construct Tray Case
• 10889981387419: Long Construct Tray, Level 1
• 10889981387402: Guidewire Caddy
• 10889981387396: Guidewire Caddy Cap
• 10889981375164: Shank, 6.5mm X 95mm
• 10889981375157: Shank, 6.5mm X 45mm
• 10889981375140: Shank, 6.5mm X 30mm
• 10889981375133: Shank, 6.5mm X 25mm
• 10889981375126: Shank, 6.0mm X 120mm
• 10889981375119: Shank, 8.5mm X 45mm