Elegance® Anterior Cervical Plate 53430115

GUDID 03700780644421

ELEGANCE 1 LEVEL CERVICAL PLATE 15MM

CLARIANCE

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 03700780644421
• NIH Device Record Key: 2fadedcc-b5d5-49e5-9a3d-40b4a36d9119
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elegance® Anterior Cervical Plate
• Version Model Number: 53430115
• Catalog Number: 53430115
• Company DUNS: 296568400
• Company Name: CLARIANCE
• 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

Customer Support Contacts

• Phone: +1 773 868 7041
• Email: s.chambat@clariance-spine.us
• Phone: +1 773 868 7041
• Email: s.chambat@clariance-spine.us
• Phone: +1 773 868 7041
• Email: s.chambat@clariance-spine.us
• Phone: +1 773 868 7041
• Email: s.chambat@clariance-spine.us
• Phone: +1 773 868 7041
• Email: s.chambat@clariance-spine.us
• Phone: +1 773 868 7041
• Email: s.chambat@clariance-spine.us
• Phone: +1 773 868 7041
• Email: s.chambat@clariance-spine.us
• Phone: +1 773 868 7041
• Email: s.chambat@clariance-spine.us
• Phone: +1 773 868 7041
• Email: s.chambat@clariance-spine.us
• Phone: +1 773 868 7041
• Email: s.chambat@clariance-spine.us
• Phone: +1 773 868 7041
• Email: s.chambat@clariance-spine.us
• Phone: +1 773 868 7041
• Email: s.chambat@clariance-spine.us
• Phone: +1 773 868 7041
• Email: s.chambat@clariance-spine.us
• Phone: +1 773 868 7041
• Email: s.chambat@clariance-spine.us
• Phone: +1 773 868 7041
• Email: s.chambat@clariance-spine.us
• Phone: +1 773 868 7041
• Email: s.chambat@clariance-spine.us
• Phone: +1 773 868 7041
• Email: s.chambat@clariance-spine.us

Device Identifiers

Device Issuing Agency	Device ID
GS1	03700780644421 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243904

FDA Product Code

• KWQ: Appliance, Fixation, Spinal Intervertebral Body

Sterilization

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

[03700780644421]

Moist Heat or Steam Sterilization

[03700780644421]

Moist Heat or Steam Sterilization

[03700780644421]

Moist Heat or Steam Sterilization

[03700780644421]

Moist Heat or Steam Sterilization

[03700780644421]

Moist Heat or Steam Sterilization

[03700780644421]

Moist Heat or Steam Sterilization

[03700780644421]

Moist Heat or Steam Sterilization

[03700780644421]

Moist Heat or Steam Sterilization

[03700780644421]

Moist Heat or Steam Sterilization

[03700780644421]

Moist Heat or Steam Sterilization

[03700780644421]

Moist Heat or Steam Sterilization

[03700780644421]

Moist Heat or Steam Sterilization

[03700780644421]

Moist Heat or Steam Sterilization

[03700780644421]

Moist Heat or Steam Sterilization

[03700780644421]

Moist Heat or Steam Sterilization

[03700780644421]

Moist Heat or Steam Sterilization

[03700780644421]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-01-30
• Device Publish Date: 2025-01-22

On-Brand Devices [Elegance® Anterior Cervical Plate]

• 03700780645015: ELEGANCE 5 LEVEL CERVICAL PLATE 110MM
• 03700780645008: ELEGANCE 5 LEVEL CERVICAL PLATE 100MM
• 03700780644995: ELEGANCE 5 LEVEL CERVICAL PLATE 90MM
• 03700780644988: ELEGANCE 5 LEVEL CERVICAL PLATE 80MM
• 03700780644971: SELF DRILLING VARIABLE SCREW
• 03700780644964: SELF DRILLING VARIABLE SCREW
• 03700780644957: SELF DRILLING VARIABLE SCREW
• 03700780644940: SELF DRILLING VARIABLE SCREW
• 03700780644933: SELF TAPPING VARIABLE SCREW
• 03700780644926: SELF TAPPING VARIABLE SCREW
• 03700780644919: SELF TAPPING VARIABLE SCREW
• 03700780644902: SELF TAPPING VARIABLE SCREW
• 03700780644896: SELF TAPPING VARIABLE SCREW
• 03700780644889: SELF TAPPING VARIABLE SCREW
• 03700780644872: SELF TAPPING VARIABLE SCREW
• 03700780644865: SELF TAPPING VARIABLE SCREW
• 03700780644858: SELF DRILLING FIXED SCREW
• 03700780644841: SELF DRILLING FIXED SCREW
• 03700780644834: SELF DRILLING FIXED SCREW
• 03700780644827: SELF DRILLING FIXED SCREW
• 03700780644810: SELF TAPPING FIXED SCREW
• 03700780644803: SELF TAPPING FIXED SCREW
• 03700780644797: SELF TAPPING FIXED SCREW
• 03700780644780: SELF TAPPING FIXED SCREW
• 03700780644773: SELF TAPPING FIXED SCREW
• 03700780644766: SELF TAPPING FIXED SCREW
• 03700780644759: SELF TAPPING FIXED SCREW
• 03700780644742: SELF TAPPING FIXED SCREW
• 03700780644735: ELEGANCE 4 LEVEL CERVICAL PLATE 84MM
• 03700780644728: ELEGANCE 4 LEVEL CERVICAL PLATE 80MM
• 03700780644711: ELEGANCE 4 LEVEL CERVICAL PLATE 76MM
• 03700780644704: ELEGANCE 4 LEVEL CERVICAL PLATE 72MM
• 03700780644698: ELEGANCE 4 LEVEL CERVICAL PLATE 68MM
• 03700780644681: ELEGANCE 4 LEVEL CERVICAL PLATE 64MM
• 03700780644674: ELEGANCE 4 LEVEL CERVICAL PLATE 60MM
• 03700780644667: ELEGANCE 3 LEVEL CERVICAL PLATE 62MM
• 03700780644650: ELEGANCE 3 LEVEL CERVICAL PLATE 59MM
• 03700780644643: ELEGANCE 3 LEVEL CERVICAL PLATE 56MM
• 03700780644636: ELEGANCE 3 LEVEL CERVICAL PLATE 53MM
• 03700780644629: ELEGANCE 3 LEVEL CERVICAL PLATE 50MM
• 03700780644612: ELEGANCE 3 LEVEL CERVICAL PLATE 47MM
• 03700780644605: ELEGANCE 3 LEVEL CERVICAL PLATE 44MM
• 03700780644599: ELEGANCE 3 LEVEL CERVICAL PLATE 41MM
• 03700780644582: ELEGANCE 3 LEVEL CERVICAL PLATE 38MM
• 03700780644575: ELEGANCE 2 LEVEL CERVICAL PLATE 40MM
• 03700780644568: ELEGANCE 2 LEVEL CERVICAL PLATE 38MM
• 03700780644551: ELEGANCE 2 LEVEL CERVICAL PLATE 36MM
• 03700780644544: ELEGANCE 2 LEVEL CERVICAL PLATE 34MM
• 03700780644537: ELEGANCE 2 LEVEL CERVICAL PLATE 32MM
• 03700780644520: ELEGANCE 2 LEVEL CERVICAL PLATE 30MM