Slimplicity Plus 66-SF-4512-B

GUDID 00840019915717

Fixed Blunt Screws 4.5mm x 12mm

PRECISION SPINE, INC.

Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable

• Primary Device ID: 00840019915717
• NIH Device Record Key: 9c195c4c-052c-4da9-aa91-b9798ba024e3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Slimplicity Plus
• Version Model Number: 66-SF-4512-B
• Catalog Number: 66-SF-4512-B
• Company DUNS: 079398589
• Company Name: PRECISION 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: false
• Lot Batch: false
• 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	00840019915717 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060025

FDA Product Code

• KWQ: Appliance, Fixation, Spinal Intervertebral Body

Sterilization

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

[00840019915717]

Moist Heat or Steam Sterilization

[00840019915717]

Moist Heat or Steam Sterilization

[00840019915717]

Moist Heat or Steam Sterilization

[00840019915717]

Moist Heat or Steam Sterilization

[00840019915717]

Moist Heat or Steam Sterilization

[00840019915717]

Moist Heat or Steam Sterilization

[00840019915717]

Moist Heat or Steam Sterilization

[00840019915717]

Moist Heat or Steam Sterilization

[00840019915717]

Moist Heat or Steam Sterilization

[00840019915717]

Moist Heat or Steam Sterilization

[00840019915717]

Moist Heat or Steam Sterilization

[00840019915717]

Moist Heat or Steam Sterilization

[00840019915717]

Moist Heat or Steam Sterilization

[00840019915717]

Moist Heat or Steam Sterilization

[00840019915717]

Moist Heat or Steam Sterilization

[00840019915717]

Moist Heat or Steam Sterilization

[00840019915717]

Moist Heat or Steam Sterilization

[00840019915717]

Moist Heat or Steam Sterilization

[00840019915717]

Moist Heat or Steam Sterilization

[00840019915717]

Moist Heat or Steam Sterilization

[00840019915717]

Moist Heat or Steam Sterilization

[00840019915717]

Moist Heat or Steam Sterilization

[00840019915717]

Moist Heat or Steam Sterilization

[00840019915717]

Moist Heat or Steam Sterilization

[00840019915717]

Moist Heat or Steam Sterilization

[00840019915717]

Moist Heat or Steam Sterilization

[00840019915717]

Moist Heat or Steam Sterilization

[00840019915717]

Moist Heat or Steam Sterilization

[00840019915717]

Moist Heat or Steam Sterilization

[00840019915717]

Moist Heat or Steam Sterilization

[00840019915717]

Moist Heat or Steam Sterilization

[00840019915717]

Moist Heat or Steam Sterilization

[00840019915717]

Moist Heat or Steam Sterilization

[00840019915717]

Moist Heat or Steam Sterilization

[00840019915717]

Moist Heat or Steam Sterilization

[00840019915717]

Moist Heat or Steam Sterilization

[00840019915717]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-04-09
• Device Publish Date: 2019-03-27

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