Kinetic SL Instruments 2019-0019

GUDID 00190837033453

15° SL Drill Guide, No Tangs

Life Spine, Inc.

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 00190837033453
• NIH Device Record Key: f6d37ff8-16e8-4593-9910-0441c3581956
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kinetic SL Instruments
• Version Model Number: 2019-0019
• Catalog Number: 2019-0019
• 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	00190837033453 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K073479

FDA Product Code

• KWQ: Appliance, fixation, spinal intervertebral body

Sterilization

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

[00190837033453]

Moist Heat or Steam Sterilization

[00190837033453]

Moist Heat or Steam Sterilization

[00190837033453]

Moist Heat or Steam Sterilization

[00190837033453]

Moist Heat or Steam Sterilization

[00190837033453]

Moist Heat or Steam Sterilization

[00190837033453]

Moist Heat or Steam Sterilization

[00190837033453]

Moist Heat or Steam Sterilization

[00190837033453]

Moist Heat or Steam Sterilization

[00190837033453]

Moist Heat or Steam Sterilization

[00190837033453]

Moist Heat or Steam Sterilization

[00190837033453]

Moist Heat or Steam Sterilization

[00190837033453]

Moist Heat or Steam Sterilization

[00190837033453]

Moist Heat or Steam Sterilization

[00190837033453]

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 [Kinetic SL Instruments]

• 00190837033453: 15° SL Drill Guide, No Tangs
• 00190837033446: 0 Degree SL Drill Guide, No Tangs