Nautilus Spinal System

GUDID 00190837007485

Life Spine, Inc.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00190837007485
• NIH Device Record Key: cb7eee7d-8129-428f-8c55-08293d2c7077
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nautilus Spinal System
• Version Model Number: 1385-30-52
• Company DUNS: 183641617
• Company Name: Life Spine, Inc.
• Device Count: 1
• DM Exempt: true
• 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	00190837007485 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111953

FDA Product Code

• NKB: Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease

Sterilization

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

[00190837007485]

Moist Heat or Steam Sterilization

[00190837007485]

Moist Heat or Steam Sterilization

[00190837007485]

Moist Heat or Steam Sterilization

[00190837007485]

Moist Heat or Steam Sterilization

[00190837007485]

Moist Heat or Steam Sterilization

[00190837007485]

Moist Heat or Steam Sterilization

[00190837007485]

Moist Heat or Steam Sterilization

[00190837007485]

Moist Heat or Steam Sterilization

[00190837007485]

Moist Heat or Steam Sterilization

[00190837007485]

Moist Heat or Steam Sterilization

[00190837007485]

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: 2016-06-09

On-Brand Devices [Nautilus Spinal System]

• 00190837021771: 485-35-52
• 00190837021764: 485-30-52
• 00190837021757: 475-55-52
• 00190837021740: 465-60-52
• 00190837021733: 465-55-52
• 00190837021726: 455-55-52
• 00190837021719: 445-50-42
• 00190837021702: 445-45-42
• 00190837021696: 445-40-42
• 00190837021689: 445-35-42
• 00190837021672: 445-30-42
• 00190837007706: 445-40-52
• 00190837007690: 445-35-52
• 00190837007683: 445-30-52
• 00190837007676: 475-50-52
• 00190837007669: 475-45-52
• 00190837007652: 475-40-52
• 00190837007645: 475-35-52
• 00190837007638: 475-30-52
• 00190837007621: 465-50-52
• 00190837007614: 465-45-52
• 00190837007607: 465-40-52
• 00190837007591: 465-35-52
• 00190837007584: 465-30-52
• 00190837007577: 455-50-52
• 00190837007560: 455-45-52
• 00190837007553: 455-40-52
• 00190837007546: 455-35-52
• 00190837007539: 455-30-52
• 00190837007522: 1385-50-52
• 00190837007515: 1385-45-52
• 00190837007508: 1385-40-52
• 00190837007492: 1385-35-52
• 00190837007485: 1385-30-52
• 00190837007478: 1375-50-52
• 00190837007461: 1375-45-52
• 00190837007454: 1375-40-52
• 00190837007447: 1375-35-52
• 00190837007430: 1375-30-52
• 00190837007423: 1365-50-52
• 00190837007416: 1365-45-52
• 00190837007409: 1365-40-52
• 00190837007393: 1365-35-52
• 00190837007386: 1365-30-52
• 00190837007379: 1355-50-52
• 00190837007362: 1355-45-52
• 00190837007355: 1355-40-52
• 00190837007348: 1355-35-52
• 00190837007331: 1355-30-52
• 00190837007324: 785-55-5