Nautilus Instruments 116-278

GUDID 00190837033415

Hook Starter, Narrow/Reduced Laminar

Life Spine, Inc.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00190837033415
• NIH Device Record Key: 3059649c-1d83-46ee-abfc-6eef5671a27c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nautilus Instruments
• Version Model Number: 116-278
• Catalog Number: 116-278
• Company DUNS: 183641617
• Company Name: Life Spine, Inc.
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00190837033415 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111953

FDA Product Code

• NKB: Thoracolumbosacral pedicle screw system

Sterilization

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

[00190837033415]

Moist Heat or Steam Sterilization

[00190837033415]

Moist Heat or Steam Sterilization

[00190837033415]

Moist Heat or Steam Sterilization

[00190837033415]

Moist Heat or Steam Sterilization

[00190837033415]

Moist Heat or Steam Sterilization

[00190837033415]

Moist Heat or Steam Sterilization

[00190837033415]

Moist Heat or Steam Sterilization

[00190837033415]

Moist Heat or Steam Sterilization

[00190837033415]

Moist Heat or Steam Sterilization

[00190837033415]

Moist Heat or Steam Sterilization

[00190837033415]

Moist Heat or Steam Sterilization

[00190837033415]

Moist Heat or Steam Sterilization

[00190837033415]

Moist Heat or Steam Sterilization

[00190837033415]

Moist Heat or Steam Sterilization

[00190837033415]

Moist Heat or Steam Sterilization

[00190837033415]

Moist Heat or Steam Sterilization

[00190837033415]

Moist Heat or Steam Sterilization

[00190837033415]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-11-15
• Device Publish Date: 2019-11-07

On-Brand Devices [Nautilus Instruments]

• 00190837033439: Angled Hook Installer
• 00190837033422: Straight Hook Installer
• 00190837033415: Hook Starter, Narrow/Reduced Laminar
• 00190837033408: Hook Starter, Wide Laminar
• 00190837033392: Hook Starter, Pedicle
• 00190837033385: Hook Impactor
• 00190837033378: Short Drill Sleeve
• 00190837033361: Drill Sleeve
• 00190837033354: 4.8mm Short Drill
• 00190837033347: 3.8mm Short Drill
• 00190837033330: 2.7mm Short Drill
• 00190837033323: 4.8mm Drill
• 00190837033316: 3.8mm Drill