SOLSTICE Instruments 2019-0064

GUDID 00190837077426

Dilation Tube

Life Spine, Inc.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00190837077426
• NIH Device Record Key: bd50642e-a3d8-45ac-b2e3-52e51fa268b4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SOLSTICE Instruments
• Version Model Number: 2019-0064
• Catalog Number: 2019-0064
• 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: 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	00190837077426 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170804

FDA Product Code

• KWP: APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Sterilization

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

[00190837077426]

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 [SOLSTICE Instruments]

• 00190837077433: Posterior Cervical Access Tube
• 00190837077426: Dilation Tube
• 00190837077419: Guide Pin, Trocar, 3.0mm
• 00190837077402: Posterior Cervical Fixation Pin, Ø2mm