Solstice Occipito-Cervico-Thoracic System

GUDID 00190837016791

Life Spine, Inc.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00190837016791
• NIH Device Record Key: e5efdce4-797e-4d40-b77d-083f8c9fd7d7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Solstice Occipito-Cervico-Thoracic System
• Version Model Number: 9235-12
• 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	00190837016791 [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

[00190837016791]

Moist Heat or Steam Sterilization

[00190837016791]

Moist Heat or Steam Sterilization

[00190837016791]

Moist Heat or Steam Sterilization

[00190837016791]

Moist Heat or Steam Sterilization

[00190837016791]

Moist Heat or Steam Sterilization

[00190837016791]

Moist Heat or Steam Sterilization

[00190837016791]

Moist Heat or Steam Sterilization

[00190837016791]

Moist Heat or Steam Sterilization

[00190837016791]

Moist Heat or Steam Sterilization

[00190837016791]

Moist Heat or Steam Sterilization

[00190837016791]

Moist Heat or Steam Sterilization

[00190837016791]

Moist Heat or Steam Sterilization

[00190837016791]

Moist Heat or Steam Sterilization

[00190837016791]

Moist Heat or Steam Sterilization

[00190837016791]

Moist Heat or Steam Sterilization

[00190837016791]

Moist Heat or Steam Sterilization

[00190837016791]

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: 2016-12-19

On-Brand Devices [Solstice Occipito-Cervico-Thoracic System]

• 00190837021566: 9335-26
• 00190837021559: 900-003
• 00190837021542: 9200-11
• 00190837017255: 9245-50
• 00190837017248: 9245-45
• 00190837017231: 9245-40
• 00190837017224: 9245-35
• 00190837017217: 9245-30
• 00190837017200: 9245-28
• 00190837017194: 9245-26
• 00190837017187: 9245-25
• 00190837017170: 9245-24
• 00190837017163: 9245-22
• 00190837017156: 9245-20
• 00190837017149: 9245-18
• 00190837017132: 9245-16
• 00190837017125: 9245-14
• 00190837017118: 9245-12
• 00190837017101: 9245-10
• 00190837017095: 9240-50
• 00190837017088: 9240-45
• 00190837017071: 9240-40
• 00190837017064: 9240-35
• 00190837017057: 9240-30
• 00190837017040: 9240-28
• 00190837017033: 9240-26
• 00190837017026: 9240-25
• 00190837017019: 9240-24
• 00190837017002: 9240-22
• 00190837016999: 9240-20
• 00190837016982: 9240-18
• 00190837016975: 9240-16
• 00190837016968: 9240-14
• 00190837016951: 9240-12
• 00190837016944: 9240-10
• 00190837016937: 9235-50
• 00190837016920: 9235-45
• 00190837016913: 9235-40
• 00190837016906: 9235-35
• 00190837016890: 9235-30
• 00190837016883: 9235-28
• 00190837016876: 9235-26
• 00190837016869: 9235-25
• 00190837016852: 9235-24
• 00190837016845: 9235-22
• 00190837016838: 9235-20
• 00190837016821: 9235-18
• 00190837016814: 9235-16
• 00190837016807: 9235-14
• 00190837016791: 9235-12