EMERGE Anterior Cervical Plate System 100-1L28

GUDID 00195860012796

1 LEVEL PLATE 28 mm

Evolution Spine LLC

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 00195860012796
• NIH Device Record Key: c49731dc-e3f5-4461-963b-19550b4e701a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EMERGE Anterior Cervical Plate System
• Version Model Number: 100-1L28
• Catalog Number: 100-1L28
• 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
• 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

• Device Size Text, specify: 0
• Length: 28 Millimeter
• Device Size Text, specify: 0
• Length: 28 Millimeter
• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
• Length: 28 Millimeter
• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
• Length: 28 Millimeter
• Device Size Text, specify: 0
• Length: 28 Millimeter
• Device Size Text, specify: 0
• Length: 28 Millimeter
• Device Size Text, specify: 0
• Length: 28 Millimeter
• Device Size Text, specify: 0
• Length: 28 Millimeter
• Device Size Text, specify: 0
• Length: 28 Millimeter
• Device Size Text, specify: 0
• Length: 28 Millimeter
• Device Size Text, specify: 0
• Length: 28 Millimeter
• Device Size Text, specify: 0
• Length: 28 Millimeter
• Device Size Text, specify: 0
• Length: 28 Millimeter
• Device Size Text, specify: 0
• Length: 28 Millimeter
• Device Size Text, specify: 0
• Length: 28 Millimeter
• Device Size Text, specify: 0
• Length: 28 Millimeter
• Device Size Text, specify: 0
• Length: 28 Millimeter
• Device Size Text, specify: 0
• Length: 28 Millimeter
• Device Size Text, specify: 0
• Length: 28 Millimeter
• Device Size Text, specify: 0
• Length: 28 Millimeter
• Device Size Text, specify: 0
• Length: 28 Millimeter
• Device Size Text, specify: 0
• Length: 28 Millimeter
• Device Size Text, specify: 0
• Length: 28 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00195860012796 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212405

FDA Product Code

• KWQ: Appliance, fixation, spinal intervertebral body

Sterilization

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

[00195860012796]

Moist Heat or Steam Sterilization

[00195860012796]

Moist Heat or Steam Sterilization

[00195860012796]

Moist Heat or Steam Sterilization

[00195860012796]

Moist Heat or Steam Sterilization

[00195860012796]

Moist Heat or Steam Sterilization

[00195860012796]

Moist Heat or Steam Sterilization

[00195860012796]

Moist Heat or Steam Sterilization

[00195860012796]

Moist Heat or Steam Sterilization

[00195860012796]

Moist Heat or Steam Sterilization

[00195860012796]

Moist Heat or Steam Sterilization

[00195860012796]

Moist Heat or Steam Sterilization

[00195860012796]

Moist Heat or Steam Sterilization

[00195860012796]

Moist Heat or Steam Sterilization

[00195860012796]

Moist Heat or Steam Sterilization

[00195860012796]

Moist Heat or Steam Sterilization

[00195860012796]

Moist Heat or Steam Sterilization

[00195860012796]

Moist Heat or Steam Sterilization

[00195860012796]

Moist Heat or Steam Sterilization

[00195860012796]

Moist Heat or Steam Sterilization

[00195860012796]

Moist Heat or Steam Sterilization

[00195860012796]

Moist Heat or Steam Sterilization

[00195860012796]

Moist Heat or Steam Sterilization

[00195860012796]

Moist Heat or Steam Sterilization

[00195860012796]

Moist Heat or Steam Sterilization

[00195860012796]

Moist Heat or Steam Sterilization

[00195860012796]

Moist Heat or Steam Sterilization

[00195860012796]

Moist Heat or Steam Sterilization

[00195860012796]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-11-09
• Device Publish Date: 2021-11-01

On-Brand Devices [EMERGE Anterior Cervical Plate System]

• 00195860015810: EMERGE System Tag
• 00195860015766: Implant Tray
• 00195860015759: Fixed Screw Caddy
• 00195860015742: Variable Screw Caddy
• 00195860015735: 5 Level Caddy
• 00195860015728: 4 Level Caddy
• 00195860015711: 3 Level Caddy
• 00195860015704: 1/2 Level Caddy
• 00195860015698: Instrument Tray 1
• 00195860015681: Outer Tub Tag
• 00195860015643: Tapered Driver Sleeve
• 00195860015605: Tapered Sleeve Driver Size 10
• 00195860015599: Punch Awl
• 00195860015476: SHORT PULL HANDLE A/O
• 00195860015469: RATCHETING HANDLE A/O
• 00195860015452: PLATE BENDER
• 00195860014899: REUSABLE DRILL 20 mm
• 00195860014882: REUSABLE DRILL 18 mm
• 00195860014875: REUSABLE DRILL 16 mm
• 00195860014868: REUSABLE DRILL 14 mm
• 00195860014851: REUSABLE DRILL 12 mm
• 00195860014844: REUSABLE DRILL 10 mm
• 00195860014837: REUSABLE AWL 20 mm
• 00195860014820: REUSABLE AWL 18 mm
• 00195860014813: REUSABLE AWL 16 mm
• 00195860014806: REUSABLE AWL 14 mm
• 00195860014790: REUSABLE AWL 12 mm
• 00195860014776: CERVICAL AWL 10 mm
• 00195860014769: FIXED TAPPING CERVICAL SCREW DIA 4.25 X 26 mm
• 00195860014752: FIXED TAPPING CERVICAL SCREW DIA 4.25 X 24 mm
• 00195860014745: FIXED TAPPING CERVICAL SCREW DIA 4.25 X 22 mm
• 00195860014738: FIXED TAPPING CERVICAL SCREW DIA 4.25 X 20 mm
• 00195860014721: FIXED TAPPING CERVICAL SCREW DIA 4.25 X 18 mm
• 00195860014714: FIXED TAPPING CERVICAL SCREW DIA 4.25 X 16 mm
• 00195860014707: FIXED TAPPING CERVICAL SCREW DIA 4.25 X 14 mm
• 00195860014691: FIXED TAPPING CERVICAL SCREW DIA 4.25 X 12 mm
• 00195860014684: FIXED TAPPING CERVICAL SCREW DIA 4.25 X 10 mm
• 00195860014677: FIXED TAPPING CERVICAL SCREW DIA 4.00 X 26 mm
• 00195860014660: FIXED TAPPING CERVICAL SCREW DIA 4.00 X 24 mm
• 00195860014653: FIXED TAPPING CERVICAL SCREW DIA 4.00 X 22 mm
• 00195860014646: FIXED TAPPING CERVICAL SCREW DIA 4.00 X 20 mm
• 00195860014639: FIXED TAPPING CERVICAL SCREW DIA 4.00 X 18 mm
• 00195860014622: FIXED TAPPING CERVICAL SCREW DIA 4.00 X 16 mm
• 00195860014615: FIXED TAPPING CERVICAL SCREW DIA 4.00 X 14 mm
• 00195860014608: FIXED TAPPING CERVICAL SCREW DIA 4.00 X 12 mm
• 00195860014592: FIXED TAPPING CERVICAL SCREW DIA 4.00 X 10 mm
• 00195860014585: FIXED TAPPING CERVICAL SCREW DIA 3.75 X 26 mm
• 00195860014578: FIXED TAPPING CERVICAL SCREW DIA 3.75 X 24 mm
• 00195860014561: FIXED TAPPING CERVICAL SCREW DIA 3.75 X 22 mm
• 00195860014554: FIXED TAPPING CERVICAL SCREW DIA 3.75 X 20 mm