ION Facet Screw System

GUDID 00850040139013

ION Facet Screw - 6.0 x 15mm

SURGENTEC, LLC

Trans-facet-screw internal spinal fixation system, sterile

• Primary Device ID: 00850040139013
• NIH Device Record Key: 12a94ab9-3273-46bc-bd41-dd60e78cb14a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ION Facet Screw System
• Version Model Number: TI-AE-60-15
• Company DUNS: 004095409
• Company Name: SURGENTEC, 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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	00850040139013 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211855

FDA Product Code

• MRW: System, Facet Screw Spinal Device

Sterilization

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

[00850040139013]

Moist Heat or Steam Sterilization

[00850040139013]

Moist Heat or Steam Sterilization

[00850040139013]

Moist Heat or Steam Sterilization

[00850040139013]

Moist Heat or Steam Sterilization

[00850040139013]

Moist Heat or Steam Sterilization

[00850040139013]

Moist Heat or Steam Sterilization

[00850040139013]

Moist Heat or Steam Sterilization

[00850040139013]

Moist Heat or Steam Sterilization

[00850040139013]

Moist Heat or Steam Sterilization

[00850040139013]

Moist Heat or Steam Sterilization

[00850040139013]

Moist Heat or Steam Sterilization

[00850040139013]

Moist Heat or Steam Sterilization

[00850040139013]

Moist Heat or Steam Sterilization

[00850040139013]

Moist Heat or Steam Sterilization

[00850040139013]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-04-28
• Device Publish Date: 2022-04-20

On-Brand Devices [ION Facet Screw System]

• 00858406007990: ION Facet Screw - 5.5 x 45mm
• 00858406007983: ION Facet Screw - 5.5 x 35mm
• 00858406007976: ION Facet Screw - 5.5 x 25mm
• 00858406007969: ION Facet Screw - 5.5 x 15mm
• 00858406007952: ION Facet Screw - 5.5 x 10mm
• 00850040139099: ION Facet Screw - 6.5 x 45mm
• 00850040139082: ION Facet Screw - 6.5 x 35mm
• 00850040139075: ION Facet Screw - 6.5 x 25mm
• 00850040139068: ION Facet Screw - 6.5 x 15mm
• 00850040139051: ION Facet Screw - 6.5 x 10mm
• 00850040139044: ION Facet Screw - 6.0 x 45mm
• 00850040139037: ION Facet Screw - 6.0 x 35mm
• 00850040139020: ION Facet Screw - 6.0 x 25mm
• 00850040139013: ION Facet Screw - 6.0 x 15mm
• 00850040139006: ION Facet Screw - 6.0 x 10mm