Cranial Fusion 117-1109

GUDID 00190837085278

Life Spine, Inc.

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 00190837085278
• NIH Device Record Key: f0b801b6-4fd2-4866-912b-4e6ba5983888
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cranial Fusion
• Version Model Number: 117-1109
• Catalog Number: 117-1109
• 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	00190837085278 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162266

FDA Product Code

• KWP: APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Sterilization

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

[00190837085278]

Moist Heat or Steam Sterilization

[00190837085278]

Moist Heat or Steam Sterilization

[00190837085278]

Moist Heat or Steam Sterilization

[00190837085278]

Moist Heat or Steam Sterilization

[00190837085278]

Moist Heat or Steam Sterilization

[00190837085278]

Moist Heat or Steam Sterilization

[00190837085278]

Moist Heat or Steam Sterilization

[00190837085278]

Moist Heat or Steam Sterilization

[00190837085278]

Moist Heat or Steam Sterilization

[00190837085278]

Moist Heat or Steam Sterilization

[00190837085278]

Moist Heat or Steam Sterilization

[00190837085278]

Moist Heat or Steam Sterilization

[00190837085278]

Moist Heat or Steam Sterilization

[00190837085278]

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 [Cranial Fusion]

• 00190837085377: 9355-14
• 00190837085360: 9355-12
• 00190837085353: 9355-10
• 00190837085346: 9355-08
• 00190837085339: 9355-06
• 00190837085322: 9350-14
• 00190837085315: 9350-13
• 00190837085308: 9350-12
• 00190837085292: 9350-11
• 00190837085285: 9350-10
• 00190837085278: 117-1109
• 00190837085261: 117-1108
• 00190837085254: 117-1107
• 00190837085247: 117-1106
• 00190837085230: 114-377-5
• 00190837085223: 114-377-4
• 00190837085216: 114-377-3
• 00190837085209: 114-377-2
• 00190837085193: 114-377-1
• 00190837085186: 113-106