Solstice

GUDID 00190837142315

Life Spine, Inc.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00190837142315
• NIH Device Record Key: d4fa7d94-6ace-42ab-8935-660c502e00c9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Solstice
• Version Model Number: 9445-35
• 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	00190837142315 [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

[00190837142315]

Moist Heat or Steam Sterilization

[00190837142315]

Moist Heat or Steam Sterilization

[00190837142315]

Moist Heat or Steam Sterilization

[00190837142315]

Moist Heat or Steam Sterilization

[00190837142315]

Moist Heat or Steam Sterilization

[00190837142315]

Moist Heat or Steam Sterilization

[00190837142315]

Moist Heat or Steam Sterilization

[00190837142315]

Moist Heat or Steam Sterilization

[00190837142315]

Moist Heat or Steam Sterilization

[00190837142315]

Moist Heat or Steam Sterilization

[00190837142315]

Moist Heat or Steam Sterilization

[00190837142315]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-03-14
• Device Publish Date: 2022-03-04

On-Brand Devices [Solstice]

• 00190837069056: Solstice Smooth Shaft Assembly, 4.0 x 34mm long
• 00190837069049: Solstice Smooth Shaft Assembly, 4.0 x 32mm long
• 00190837069032: Solstice Smooth Shaft Assembly, 4.0 x 18mm long
• 00190837069025: Solstice Smooth Shaft Assembly, 3.5 x 34mm long
• 00190837069018: Solstice Smooth Shaft Assembly, 3.5 x 32mm long
• 00190837069001: Solstice Smooth Shaft Assembly, 3.5 x 30mm long
• 00190837068998: Solstice Smooth Shaft Assembly, 3.5 x 28mm long
• 00190837068981: Solstice Smooth Shaft Assembly, 3.5 x 26mm long
• 00190837068974: Solstice Smooth Shaft Assembly, 3.5 x 24mm long
• 00190837068967: Solstice Smooth Shaft Assembly, 3.5 x 22mm long
• 00190837068950: Solstice Smooth Shaft Assembly, 3.5 x 20mm long
• 00190837068943: Solstice Smooth Shaft Assembly, 3.5 x 18mm long
• 00190837031466: 4.0mm SOLSTICE® Smooth Shaft Poly Screw, 30mm
• 00190837031459: 4.0mm SOLSTICE® Smooth Shaft Poly Screw, 28mm
• 00190837031442: 4.0mm SOLSTICE® Smooth Shaft Poly Screw, 26mm
• 00190837031435: 4.0mm SOLSTICE® Smooth Shaft Poly Screw, 24mm
• 00190837031428: 4.0mm SOLSTICE® Smooth Shaft Poly Screw, 22mm
• 00190837031411: 4.0mm SOLSTICE® Smooth Shaft Poly Screw, 20mm
• 00190837085612: 2019-0074
• 00190837085605: 2019-0073
• 00190837081973: 112-227
• 00190837081966: 112-225
• 00190837081959: 112-220
• 00190837079246: 2019-0068
• 00190837034641: Cervical Hook Starter, 6.0mm
• 00190837034634: Cervical Hook Starter, 4.5mm
• 00190837031725: 3.5mm x 110mm Pre-Lordosed Rod
• 00190837031718: 3.5mm x 100mm Pre-Lordosed Rod
• 00190837031701: 3.5mm x 90mm Pre-Lordosed Rod
• 00190837031688: 3.5mm x 70mm Pre-Lordosed Rod
• 00190837031671: 3.5mm x 60mm Pre-Lordosed Rod
• 00190837031664: 3.5mm x 50mm Pre-Lordosed Rod
• 00190837031657: 3.5mm x 40mm Pre-Lordosed Rod
• 00190837142315: 9445-35