Defender™ Anterior Cervical Plate System 15-5112

GUDID 10840642166682

1 Level Plate, 12 mm

Spine Wave, Inc.

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 10840642166682
• NIH Device Record Key: cdec111f-79f8-4256-b814-241e2c475515
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Defender™ Anterior Cervical Plate System
• Version Model Number: 15-5112
• Catalog Number: 15-5112
• Company DUNS: 067789763
• Company Name: Spine Wave, Inc.
• 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: 203-944-9494
• Email: GUDID@spinewave.com
• Phone: 203-944-9494
• Email: GUDID@spinewave.com
• Phone: 203-944-9494
• Email: GUDID@spinewave.com
• Phone: 203-944-9494
• Email: GUDID@spinewave.com
• Phone: 203-944-9494
• Email: GUDID@spinewave.com
• Phone: 203-944-9494
• Email: GUDID@spinewave.com
• Phone: 203-944-9494
• Email: GUDID@spinewave.com
• Phone: 203-944-9494
• Email: GUDID@spinewave.com
• Phone: 203-944-9494
• Email: GUDID@spinewave.com
• Phone: 203-944-9494
• Email: GUDID@spinewave.com
• Phone: 203-944-9494
• Email: GUDID@spinewave.com
• Phone: 203-944-9494
• Email: GUDID@spinewave.com
• Phone: 203-944-9494
• Email: GUDID@spinewave.com
• Phone: 203-944-9494
• Email: GUDID@spinewave.com
• Phone: 203-944-9494
• Email: GUDID@spinewave.com
• Phone: 203-944-9494
• Email: GUDID@spinewave.com
• Phone: 203-944-9494
• Email: GUDID@spinewave.com
• Phone: 203-944-9494
• Email: GUDID@spinewave.com
• Phone: 203-944-9494
• Email: GUDID@spinewave.com
• Phone: 203-944-9494
• Email: GUDID@spinewave.com
• Phone: 203-944-9494
• Email: GUDID@spinewave.com
• Phone: 203-944-9494
• Email: GUDID@spinewave.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10840642166682 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182489

FDA Product Code

• KWQ: Appliance, Fixation, Spinal Intervertebral Body

Sterilization

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

[10840642166682]

Moist Heat or Steam Sterilization

[10840642166682]

Moist Heat or Steam Sterilization

[10840642166682]

Moist Heat or Steam Sterilization

[10840642166682]

Moist Heat or Steam Sterilization

[10840642166682]

Moist Heat or Steam Sterilization

[10840642166682]

Moist Heat or Steam Sterilization

[10840642166682]

Moist Heat or Steam Sterilization

[10840642166682]

Moist Heat or Steam Sterilization

[10840642166682]

Moist Heat or Steam Sterilization

[10840642166682]

Moist Heat or Steam Sterilization

[10840642166682]

Moist Heat or Steam Sterilization

[10840642166682]

Moist Heat or Steam Sterilization

[10840642166682]

Moist Heat or Steam Sterilization

[10840642166682]

Moist Heat or Steam Sterilization

[10840642166682]

Moist Heat or Steam Sterilization

[10840642166682]

Moist Heat or Steam Sterilization

[10840642166682]

Moist Heat or Steam Sterilization

[10840642166682]

Moist Heat or Steam Sterilization

[10840642166682]

Moist Heat or Steam Sterilization

[10840642166682]

Moist Heat or Steam Sterilization

[10840642166682]

Moist Heat or Steam Sterilization

[10840642166682]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-08-13
• Device Publish Date: 2021-08-05

On-Brand Devices [Defender™ Anterior Cervical Plate System]

• 10840642167276: Fixed Self-Drilling Screw, ø4.35 mm X 10 mm
• 10840642167269: Fixed Self-Drilling Screw, ø4.0 mm X 22 mm
• 10840642167252: Fixed Self-Drilling Screw, ø4.0 mm X 20 mm
• 10840642167238: Fixed Self-Drilling Screw, ø4.0 mm X 18 mm
• 10840642167214: Fixed Self-Drilling Screw, ø4.0 mm X 16 mm
• 10840642167191: Fixed Self-Drilling Screw, ø4.0 mm X 14 mm
• 10840642167177: Fixed Self-Drilling Screw, ø4.0 mm X 12 mm
• 10840642167153: Fixed Self-Drilling Screw, ø4.0 mm X 10 mm
• 10840642167146: 5 Level Plate, 91 mm
• 10840642167139: 5 Level Plate, 86 mm
• 10840642167122: 5 Level Plate, 81 mm
• 10840642167115: 5 Level Plate, 76 mm
• 10840642167108: 5 Level Plate, 71 mm
• 10840642167092: 4 Level Plate, 78 mm
• 10840642167085: 4 Level Plate, 74 mm
• 10840642167078: 4 Level Plate, 70 mm
• 10840642167061: 4 Level Plate, 66 mm
• 10840642167054: 4 Level Plate, 62 mm
• 10840642167047: 4 Level Plate, 58 mm
• 10840642167030: 4 Level Plate, 54 mm
• 10840642167023: 4 Level Plate, 50 mm
• 10840642167016: 4 Level Plate, 46 mm
• 10840642167009: 3 Level Plate, 69 mm
• 10840642166996: 3 Level Plate, 66 mm
• 10840642166989: 3 Level Plate, 63 mm
• 10840642166972: 3 Level Plate, 60 mm
• 10840642166965: 3 Level Plate, 57 mm
• 10840642166958: 3 Level Plate, 54 mm
• 10840642166941: 3 Level Plate, 51 mm
• 10840642166934: 3 Level Plate, 48 mm
• 10840642166927: 3 Level Plate, 45 mm
• 10840642166910: 3 Level Plate, 42 mm
• 10840642166903: 3 Level Plate, 39 mm
• 10840642166897: 3 Level Plate, 36 mm
• 10840642166880: 2 Level Plate, 46 mm
• 10840642166873: 2 Level Plate, 44 mm
• 10840642166866: 2 Level Plate, 42 mm
• 10840642166859: 2 Level Plate, 40 mm
• 10840642166842: 2 Level Plate, 38 mm
• 10840642166835: 2 Level Plate, 36 mm
• 10840642166828: 2 Level Plate, 34 mm
• 10840642166811: 2 Level Plate, 32 mm
• 10840642166804: 2 Level Plate, 30 mm
• 10840642166798: 2 Level Plate, 28 mm
• 10840642166781: 2 Level Plate, 26 mm
• 10840642166774: 2 Level Plate, 24 mm
• 10840642166767: 2 Level Plate, 22 mm
• 10840642166750: 1 Level Plate, 26 mm
• 10840642166743: 1 Level Plate, 24 mm
• 10840642166736: 1 Level Plate, 22 mm