Solstice Core System 117-953-1

GUDID 00190837104535

Cervical Adjustable Depth Gauge

Life Spine, Inc.

Interspinous spinal fixation implant

• Primary Device ID: 00190837104535
• NIH Device Record Key: 9d2f75f8-f2f4-402d-9c07-8b155fb2915e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Solstice Core System
• Version Model Number: 117-953-1
• Catalog Number: 117-953-1
• 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	00190837104535 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090343

FDA Product Code

• KWP: APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Sterilization

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

[00190837104535]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-11-27
• Device Publish Date: 2019-11-19

On-Brand Devices [Solstice Core System]

• 00190837104542: 3.5mm Rod Template
• 00190837104535: Cervical Adjustable Depth Gauge
• 00190837104528: Cervical Adjustable Drill Guide
• 00190837104511: Empty Sterilization Tray