EMERGE Micro Anterior Cervical Plate System 101-1L07

GUDID 00195860016121

1 LEVEL PLATE 7mm

Evolution Spine LLC

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 00195860016121
• NIH Device Record Key: acf0ef60-e1b6-4f9d-b520-26c7a67176f3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EMERGE Micro Anterior Cervical Plate System
• Version Model Number: 101-1L07
• Catalog Number: 101-1L07
• Company DUNS: 116940934
• Company Name: Evolution Spine 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: 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

Customer Support Contacts

• Phone: +1(214)682-8536
• Email: info@evolutionspine.com
• Phone: +1(214)682-8536
• Email: info@evolutionspine.com
• Phone: +1(214)682-8536
• Email: info@evolutionspine.com
• Phone: +1(214)682-8536
• Email: info@evolutionspine.com
• Phone: +1(214)682-8536
• Email: info@evolutionspine.com
• Phone: +1(214)682-8536
• Email: info@evolutionspine.com
• Phone: +1(214)682-8536
• Email: info@evolutionspine.com
• Phone: +1(214)682-8536
• Email: info@evolutionspine.com
• Phone: +1(214)682-8536
• Email: info@evolutionspine.com
• Phone: +1(214)682-8536
• Email: info@evolutionspine.com
• Phone: +1(214)682-8536
• Email: info@evolutionspine.com
• Phone: +1(214)682-8536
• Email: info@evolutionspine.com
• Phone: +1(214)682-8536
• Email: info@evolutionspine.com
• Phone: +1(214)682-8536
• Email: info@evolutionspine.com
• Phone: +1(214)682-8536
• Email: info@evolutionspine.com
• Phone: +1(214)682-8536
• Email: info@evolutionspine.com
• Phone: +1(214)682-8536
• Email: info@evolutionspine.com
• Phone: +1(214)682-8536
• Email: info@evolutionspine.com

Device Dimensions

• Length: 7 Millimeter
• Device Size Text, specify: 0
• Length: 7 Millimeter
• Device Size Text, specify: 0
• Length: 7 Millimeter
• Device Size Text, specify: 0
• Length: 7 Millimeter
• Device Size Text, specify: 0
• Length: 7 Millimeter
• Device Size Text, specify: 0
• Length: 7 Millimeter
• Device Size Text, specify: 0
• Length: 7 Millimeter
• Device Size Text, specify: 0
• Length: 7 Millimeter
• Device Size Text, specify: 0
• Length: 7 Millimeter
• Device Size Text, specify: 0
• Length: 7 Millimeter
• Device Size Text, specify: 0
• Length: 7 Millimeter
• Device Size Text, specify: 0
• Length: 7 Millimeter
• Device Size Text, specify: 0
• Length: 7 Millimeter
• Device Size Text, specify: 0
• Length: 7 Millimeter
• Device Size Text, specify: 0
• Length: 7 Millimeter
• Device Size Text, specify: 0
• Length: 7 Millimeter
• Device Size Text, specify: 0
• Length: 7 Millimeter
• Device Size Text, specify: 0
• Length: 7 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00195860016121 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220275

FDA Product Code

• KWQ: Appliance, fixation, spinal intervertebral body

Sterilization

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

[00195860016121]

Moist Heat or Steam Sterilization

[00195860016121]

Moist Heat or Steam Sterilization

[00195860016121]

Moist Heat or Steam Sterilization

[00195860016121]

Moist Heat or Steam Sterilization

[00195860016121]

Moist Heat or Steam Sterilization

[00195860016121]

Moist Heat or Steam Sterilization

[00195860016121]

Moist Heat or Steam Sterilization

[00195860016121]

Moist Heat or Steam Sterilization

[00195860016121]

Moist Heat or Steam Sterilization

[00195860016121]

Moist Heat or Steam Sterilization

[00195860016121]

Moist Heat or Steam Sterilization

[00195860016121]

Moist Heat or Steam Sterilization

[00195860016121]

Moist Heat or Steam Sterilization

[00195860016121]

Moist Heat or Steam Sterilization

[00195860016121]

Moist Heat or Steam Sterilization

[00195860016121]

Moist Heat or Steam Sterilization

[00195860016121]

Moist Heat or Steam Sterilization

[00195860016121]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-06-21
• Device Publish Date: 2022-06-10

On-Brand Devices [EMERGE Micro Anterior Cervical Plate System]

• 00195860016428: DTS DRILL 20mm
• 00195860016411: DTS DRILL 18mm
• 00195860016404: DTS DRILL 16mm
• 00195860016398: DTS DRILL 14mm
• 00195860016381: DTS DRILL 12mm
• 00195860016374: DTS DRILL 10mm
• 00195860016367: INLINE INSERTER
• 00195860016350: INLINE INSERTER DRAWBAR
• 00195860016268: 2 LEVEL PLATE 30mm
• 00195860016251: 2 LEVEL PLATE 28mm
• 00195860016244: 2 LEVEL PLATE 26mm
• 00195860016237: 2 LEVEL PLATE 24mm
• 00195860016220: 2 LEVEL PLATE 22mm
• 00195860016213: 2 LEVEL PLATE 20mm
• 00195860016206: 2 LEVEL PLATE 18mm
• 00195860016190: 2 LEVEL PLATE 16mm
• 00195860016183: 2 LEVEL PLATE 14mm
• 00195860016176: 1 LEVEL PLATE 12mm
• 00195860016169: 1 LEVEL PLATE 11mm
• 00195860016152: 1 LEVEL PLATE 10mm
• 00195860016145: 1 LEVEL PLATE 9mm
• 00195860016138: 1 LEVEL PLATE 8mm
• 00195860016121: 1 LEVEL PLATE 7mm
• 00195860016114: 1 LEVEL PLATE 6mm
• 00195860016107: 1 LEVEL PLATE 5mm
• 00195860016435: DTS GUIDE 9mm
• 00195860016343: DTS GUIDE 12mm
• 00195860016336: DTS GUIDE 11mm
• 00195860016329: DTS GUIDE 10mm
• 00195860016305: DTS GUIDE 8mm
• 00195860016299: DTS GUIDE 7mm
• 00195860016282: DTS GUIDE 6mm
• 00195860016275: DTS GUIDE 5mm