Nautilus CA 116-280

GUDID 00190837091088

Lenke Style Curved Probe

Life Spine, Inc.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00190837091088
• NIH Device Record Key: 7d98a6ee-573d-4e99-87b5-f929167de5c8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nautilus CA
• Version Model Number: 116-280
• Catalog Number: 116-280
• 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	00190837091088 [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

[00190837091088]

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 CA]

• 00190837087210: Hexalobe T-25 Driver Shaft, 1/4", Cannulated
• 00190837091088: Lenke Style Curved Probe
• 00190837091071: Awl, With Stop
• 00190837091064: Awl, No Stop