Monza Cervical Plate System

GUDID B41711604861

86mm Cervical Plate, 4 Level

Altus Spine, LLC

Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable
Primary Device IDB41711604861
NIH Device Record Keyac86e4eb-39b1-428e-ac8e-be2bb4074b0e
Commercial Distribution StatusIn Commercial Distribution
Brand NameMonza Cervical Plate System
Version Model Number116-0486
Company DUNS078331322
Company NameAltus Spine, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(610)355-4156
EmailInfo@altus-spine.com
Phone+1(610)355-4156
EmailInfo@altus-spine.com
Phone+1(610)355-4156
EmailInfo@altus-spine.com
Phone+1(610)355-4156
EmailInfo@altus-spine.com
Phone+1(610)355-4156
EmailInfo@altus-spine.com
Phone+1(610)355-4156
EmailInfo@altus-spine.com
Phone+1(610)355-4156
EmailInfo@altus-spine.com
Phone+1(610)355-4156
EmailInfo@altus-spine.com
Phone+1(610)355-4156
EmailInfo@altus-spine.com
Phone+1(610)355-4156
EmailInfo@altus-spine.com
Phone+1(610)355-4156
EmailInfo@altus-spine.com
Phone+1(610)355-4156
EmailInfo@altus-spine.com
Phone+1(610)355-4156
EmailInfo@altus-spine.com
Phone+1(610)355-4156
EmailInfo@altus-spine.com
Phone+1(610)355-4156
EmailInfo@altus-spine.com

Device Dimensions

Height86 Millimeter
Height86 Millimeter
Height86 Millimeter
Height86 Millimeter
Height86 Millimeter
Height86 Millimeter
Height86 Millimeter
Height86 Millimeter
Height86 Millimeter
Height86 Millimeter
Height86 Millimeter
Height86 Millimeter
Height86 Millimeter
Height86 Millimeter
Height86 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100843210110035 [Secondary]
HIBCCB41711604861 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAPPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B41711604861]

Moist Heat or Steam Sterilization

[B41711604861]

Moist Heat or Steam Sterilization

[B41711604861]

Moist Heat or Steam Sterilization

[B41711604861]

Moist Heat or Steam Sterilization

[B41711604861]

Moist Heat or Steam Sterilization

[B41711604861]

Moist Heat or Steam Sterilization

[B41711604861]

Moist Heat or Steam Sterilization

[B41711604861]

Moist Heat or Steam Sterilization

[B41711604861]

Moist Heat or Steam Sterilization

[B41711604861]

Moist Heat or Steam Sterilization

[B41711604861]

Moist Heat or Steam Sterilization

[B41711604861]

Moist Heat or Steam Sterilization

[B41711604861]

Moist Heat or Steam Sterilization

[B41711604861]

Moist Heat or Steam Sterilization

[B41711604861]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-10-28

On-Brand Devices [Monza Cervical Plate System]

008432101332633&4 Level Plate Basket Bottom, Monza
00843210133195SCP: Fixation Pin
00843210121864SSP: Screw Driver
B41713543221Rigid Self-Tapping Screw, 4.35mm x 22mm
B41713543201Rigid Self-Tapping Screw, 4.35mm x 20mm
B41713543181Rigid Self-Tapping Screw, 4.35mm x 18mm
B41713543161Rigid Self-Tapping Screw, 4.35mm x 16mm
B41713543141Rigid Self-Tapping Screw, 4.35mm x 14mm
B41713543121Rigid Self-Tapping Screw, 4.35mm x 12mm
B41713540221Rigid Self-Tapping Screw, 4.00mm x 22mm
B41713540201Rigid Self-Tapping Screw, 4.00mm x 20mm
B41713540181Rigid Self-Tapping Screw, 4.00mm x 18mm
B41713540161Rigid Self-Tapping Screw, 4.00mm x 16mm
B41713540151Rigid Self-Tapping Screw, 4.00mm x 15mm
B41713540141Rigid Self-Tapping Screw, 4.00mm x 14mm
B41713540131Rigid Self-Tapping Screw, 4.00mm x 13mm
B41713540121Rigid Self-Tapping Screw, 4.00mm x 12mm
B41712043181Self-Tapping Screw, 4.35mm x 18mm
B41712043161Self-Tapping Screw, 4.35mm x 16mm
B41712043141Self-Tapping Screw, 4.35mm x 14mm
B41712043121Self-Tapping Screw, 4.35mm x 12mm
B41712040181Self-Tapping Screw, 4.0mm x 18mm
B41712040161Self-Tapping Screw, 4.0mm x 16mm
B41712040141Self-Tapping Screw, 4.0mm x 14mm
B41712040121Self-Tapping Screw, 4.0mm x 12mm
B4171160489189mm Cervical Plate, 4 Level
B4171160486186mm Cervical Plate, 4 Level
B4171160483183mm Cervical Plate, 4 Level
B4171160480180mm Cervical Plate, 4 Level
B4171160477177mm Cervical Plate, 4 Level
B4171160474174mm Cervical Plate, 4 Level
B4171160377177mm Cervical Plate, 3 Level
B4171160374174mm Cervical Plate, 3 Level
B4171160371171mm Cervical Plate, 3 Level
B4171160368168mm Cervical Plate, 3 Level
B4171160365165mm Cervical Plate, 3 Level
B4171160362162mm Cervical Plate, 3 Level
B4171160359159mm Cervical Plate, 3 Level
B4171160356156mm Cervical Plate, 3 Level
B4171160353153mm Cervical Plate, 3 Level
B4171160350150mm Cervical Plate, 3 Level
B4171160256156mm Cervical Plate, 2 Level
B4171160253153mm Cervical Plate, 2 Level
B4171160250150mm Cervical Plate, 2 Level
B4171160247147mm Cervical Plate, 2 Level
B4171160244144mm Cervical Plate, 2 Level
B4171160241141mm Cervical Plate, 2 Level
B4171160238138mm Cervical Plate, 2 Level
B4171160235135mm Cervical Plate, 2 Level
B4171160136136mm Cervical Plate, 1 Level
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