Monza Cervical Plate System

GUDID B41711602351

35mm Cervical Plate, 2 Level

Altus Spine, LLC

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: B41711602351
• NIH Device Record Key: c2e86153-936c-4ca9-badc-1070697ebf0e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Monza Cervical Plate System
• Version Model Number: 116-0235
• Company DUNS: 078331322
• Company Name: Altus 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: 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(610)355-4156
• Email: Info@altus-spine.com
• Phone: +1(610)355-4156
• Email: Info@altus-spine.com
• Phone: +1(610)355-4156
• Email: Info@altus-spine.com
• Phone: +1(610)355-4156
• Email: Info@altus-spine.com
• Phone: +1(610)355-4156
• Email: Info@altus-spine.com
• Phone: +1(610)355-4156
• Email: Info@altus-spine.com
• Phone: +1(610)355-4156
• Email: Info@altus-spine.com
• Phone: +1(610)355-4156
• Email: Info@altus-spine.com
• Phone: +1(610)355-4156
• Email: Info@altus-spine.com
• Phone: +1(610)355-4156
• Email: Info@altus-spine.com
• Phone: +1(610)355-4156
• Email: Info@altus-spine.com
• Phone: +1(610)355-4156
• Email: Info@altus-spine.com
• Phone: +1(610)355-4156
• Email: Info@altus-spine.com
• Phone: +1(610)355-4156
• Email: Info@altus-spine.com
• Phone: +1(610)355-4156
• Email: Info@altus-spine.com

Device Dimensions

• Height: 35 Millimeter
• Height: 35 Millimeter
• Height: 35 Millimeter
• Height: 35 Millimeter
• Height: 35 Millimeter
• Height: 35 Millimeter
• Height: 35 Millimeter
• Height: 35 Millimeter
• Height: 35 Millimeter
• Height: 35 Millimeter
• Height: 35 Millimeter
• Height: 35 Millimeter
• Height: 35 Millimeter
• Height: 35 Millimeter
• Height: 35 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00843210109756 [Secondary]
HIBCC	B41711602351 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K073530

FDA Product Code

• KWQ: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Sterilization

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

[B41711602351]

Moist Heat or Steam Sterilization

[B41711602351]

Moist Heat or Steam Sterilization

[B41711602351]

Moist Heat or Steam Sterilization

[B41711602351]

Moist Heat or Steam Sterilization

[B41711602351]

Moist Heat or Steam Sterilization

[B41711602351]

Moist Heat or Steam Sterilization

[B41711602351]

Moist Heat or Steam Sterilization

[B41711602351]

Moist Heat or Steam Sterilization

[B41711602351]

Moist Heat or Steam Sterilization

[B41711602351]

Moist Heat or Steam Sterilization

[B41711602351]

Moist Heat or Steam Sterilization

[B41711602351]

Moist Heat or Steam Sterilization

[B41711602351]

Moist Heat or Steam Sterilization

[B41711602351]

Moist Heat or Steam Sterilization

[B41711602351]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-28

On-Brand Devices [Monza Cervical Plate System]

• 00843210133263: 3&4 Level Plate Basket Bottom, Monza
• 00843210133195: SCP: Fixation Pin
• 00843210121864: SSP: Screw Driver
• B41713543221: Rigid Self-Tapping Screw, 4.35mm x 22mm
• B41713543201: Rigid Self-Tapping Screw, 4.35mm x 20mm
• B41713543181: Rigid Self-Tapping Screw, 4.35mm x 18mm
• B41713543161: Rigid Self-Tapping Screw, 4.35mm x 16mm
• B41713543141: Rigid Self-Tapping Screw, 4.35mm x 14mm
• B41713543121: Rigid Self-Tapping Screw, 4.35mm x 12mm
• B41713540221: Rigid Self-Tapping Screw, 4.00mm x 22mm
• B41713540201: Rigid Self-Tapping Screw, 4.00mm x 20mm
• B41713540181: Rigid Self-Tapping Screw, 4.00mm x 18mm
• B41713540161: Rigid Self-Tapping Screw, 4.00mm x 16mm
• B41713540151: Rigid Self-Tapping Screw, 4.00mm x 15mm
• B41713540141: Rigid Self-Tapping Screw, 4.00mm x 14mm
• B41713540131: Rigid Self-Tapping Screw, 4.00mm x 13mm
• B41713540121: Rigid Self-Tapping Screw, 4.00mm x 12mm
• B41712043181: Self-Tapping Screw, 4.35mm x 18mm
• B41712043161: Self-Tapping Screw, 4.35mm x 16mm
• B41712043141: Self-Tapping Screw, 4.35mm x 14mm
• B41712043121: Self-Tapping Screw, 4.35mm x 12mm
• B41712040181: Self-Tapping Screw, 4.0mm x 18mm
• B41712040161: Self-Tapping Screw, 4.0mm x 16mm
• B41712040141: Self-Tapping Screw, 4.0mm x 14mm
• B41712040121: Self-Tapping Screw, 4.0mm x 12mm
• B41711604891: 89mm Cervical Plate, 4 Level
• B41711604861: 86mm Cervical Plate, 4 Level
• B41711604831: 83mm Cervical Plate, 4 Level
• B41711604801: 80mm Cervical Plate, 4 Level
• B41711604771: 77mm Cervical Plate, 4 Level
• B41711604741: 74mm Cervical Plate, 4 Level
• B41711603771: 77mm Cervical Plate, 3 Level
• B41711603741: 74mm Cervical Plate, 3 Level
• B41711603711: 71mm Cervical Plate, 3 Level
• B41711603681: 68mm Cervical Plate, 3 Level
• B41711603651: 65mm Cervical Plate, 3 Level
• B41711603621: 62mm Cervical Plate, 3 Level
• B41711603591: 59mm Cervical Plate, 3 Level
• B41711603561: 56mm Cervical Plate, 3 Level
• B41711603531: 53mm Cervical Plate, 3 Level
• B41711603501: 50mm Cervical Plate, 3 Level
• B41711602561: 56mm Cervical Plate, 2 Level
• B41711602531: 53mm Cervical Plate, 2 Level
• B41711602501: 50mm Cervical Plate, 2 Level
• B41711602471: 47mm Cervical Plate, 2 Level
• B41711602441: 44mm Cervical Plate, 2 Level
• B41711602411: 41mm Cervical Plate, 2 Level
• B41711602381: 38mm Cervical Plate, 2 Level
• B41711602351: 35mm Cervical Plate, 2 Level
• B41711601361: 36mm Cervical Plate, 1 Level