MEDIANT 121302

GUDID 00814033021266

Mediant Positioning Pins, Re-usable

INTELLIGENT IMPLANT SYSTEMS, LLC

Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 00814033021266
• NIH Device Record Key: 2aa4631c-386b-4c2f-a323-922b7e4297b9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MEDIANT
• Version Model Number: 121302
• Catalog Number: 121302
• Company DUNS: 013742030
• Company Name: INTELLIGENT IMPLANT SYSTEMS, LLC
• 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	00814033021266 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173935

FDA Product Code

• KWQ: Appliance, Fixation, Spinal Intervertebral Body

Sterilization

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

[00814033021266]

Moist Heat or Steam Sterilization

[00814033021266]

Moist Heat or Steam Sterilization

[00814033021266]

Moist Heat or Steam Sterilization

[00814033021266]

Moist Heat or Steam Sterilization

[00814033021266]

Moist Heat or Steam Sterilization

[00814033021266]

Moist Heat or Steam Sterilization

[00814033021266]

Moist Heat or Steam Sterilization

[00814033021266]

Moist Heat or Steam Sterilization

[00814033021266]

Moist Heat or Steam Sterilization

[00814033021266]

Moist Heat or Steam Sterilization

[00814033021266]

Moist Heat or Steam Sterilization

[00814033021266]

Moist Heat or Steam Sterilization

[00814033021266]

Moist Heat or Steam Sterilization

[00814033021266]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-06-06
• Device Publish Date: 2019-05-29

On-Brand Devices [MEDIANT]

• 00814033021280: Mediant 2.0 mm Drill
• 00814033021273: Mediant 2.0 mm Drill Guide
• 00814033021266: Mediant Positioning Pins, Re-usable