Cranial Fusion Plate System 9301-35

GUDID 00190837031381

35mm Plate

Life Spine, Inc.

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 00190837031381
• NIH Device Record Key: 16f6beaa-5095-4ac4-a3fd-f252eb684a6d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cranial Fusion Plate System
• Version Model Number: 9301-35
• Catalog Number: 9301-35
• 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	00190837031381 [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

[00190837031381]

Moist Heat or Steam Sterilization

[00190837031381]

Moist Heat or Steam Sterilization

[00190837031381]

Moist Heat or Steam Sterilization

[00190837031381]

Moist Heat or Steam Sterilization

[00190837031381]

Moist Heat or Steam Sterilization

[00190837031381]

Moist Heat or Steam Sterilization

[00190837031381]

Moist Heat or Steam Sterilization

[00190837031381]

Moist Heat or Steam Sterilization

[00190837031381]

Moist Heat or Steam Sterilization

[00190837031381]

Moist Heat or Steam Sterilization

[00190837031381]

Moist Heat or Steam Sterilization

[00190837031381]

Moist Heat or Steam Sterilization

[00190837031381]

Moist Heat or Steam Sterilization

[00190837031381]

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 Plate System]

• 00190837068936: Tri-Cortical Allograft, 4cm
• 00190837068929: Cranial Fusion Plate 35mm
• 00190837068912: Cranial Fusion Plate 30mm
• 00190837068905: Rod Bender 7 1/2" For 4 & 3mm Rods
• 00190837068899: T15 Occipital Screwdriver
• 00190837068882: Impact Sleeve
• 00190837068875: Final Dilation Tube w/ Spikes
• 00190837068868: OCT Adjustable Drill Guide, Slim
• 00190837068851: Cranial Plate Caddy
• 00190837068844: Cranial Plate Tab Bender
• 00190837068837: Drill Stop
• 00190837068820: Cranial Adjustable Drill Guide
• 00190837068813: T15 Occipital Screwdriver
• 00190837068806: 114-314
• 00190837031404: Set Screw
• 00190837031398: 40mm Plate
• 00190837031381: 35mm Plate
• 00190837031374: 30mm Plate