Anterior Cervical Plate GCP2-AV4012

GUDID M719GCP2AV40120

4.00mm x 12mm Binary Auger Tip Variable Screw

Genesys Orthopedics Systems 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 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 IDM719GCP2AV40120
NIH Device Record Keybc832e2d-c780-49e1-bda1-4711f0baa144
Commercial Distribution StatusIn Commercial Distribution
Brand NameAnterior Cervical Plate
Version Model Number1
Catalog NumberGCP2-AV4012
Company DUNS017921066
Company NameGenesys Orthopedics Systems 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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone5123817070
Emailinfo@genesysspine.com
Phone5123817070
Emailinfo@genesysspine.com
Phone5123817070
Emailinfo@genesysspine.com
Phone5123817070
Emailinfo@genesysspine.com
Phone5123817070
Emailinfo@genesysspine.com
Phone5123817070
Emailinfo@genesysspine.com
Phone5123817070
Emailinfo@genesysspine.com
Phone5123817070
Emailinfo@genesysspine.com
Phone5123817070
Emailinfo@genesysspine.com
Phone5123817070
Emailinfo@genesysspine.com
Phone5123817070
Emailinfo@genesysspine.com
Phone5123817070
Emailinfo@genesysspine.com
Phone5123817070
Emailinfo@genesysspine.com
Phone5123817070
Emailinfo@genesysspine.com
Phone5123817070
Emailinfo@genesysspine.com
Phone5123817070
Emailinfo@genesysspine.com
Phone5123817070
Emailinfo@genesysspine.com
Phone5123817070
Emailinfo@genesysspine.com
Phone5123817070
Emailinfo@genesysspine.com
Phone5123817070
Emailinfo@genesysspine.com
Phone5123817070
Emailinfo@genesysspine.com
Phone5123817070
Emailinfo@genesysspine.com
Phone5123817070
Emailinfo@genesysspine.com
Phone5123817070
Emailinfo@genesysspine.com
Phone5123817070
Emailinfo@genesysspine.com
Phone5123817070
Emailinfo@genesysspine.com
Phone5123817070
Emailinfo@genesysspine.com
Phone5123817070
Emailinfo@genesysspine.com
Phone5123817070
Emailinfo@genesysspine.com
Phone5123817070
Emailinfo@genesysspine.com

Device Dimensions

Outer Diameter4 Millimeter
Length12 Millimeter
Outer Diameter4 Millimeter
Length12 Millimeter
Outer Diameter4 Millimeter
Length12 Millimeter
Outer Diameter4 Millimeter
Length12 Millimeter
Outer Diameter4 Millimeter
Length12 Millimeter
Outer Diameter4 Millimeter
Length12 Millimeter
Outer Diameter4 Millimeter
Length12 Millimeter
Outer Diameter4 Millimeter
Length12 Millimeter
Outer Diameter4 Millimeter
Length12 Millimeter
Outer Diameter4 Millimeter
Length12 Millimeter
Outer Diameter4 Millimeter
Length12 Millimeter
Outer Diameter4 Millimeter
Length12 Millimeter
Outer Diameter4 Millimeter
Length12 Millimeter
Outer Diameter4 Millimeter
Length12 Millimeter
Outer Diameter4 Millimeter
Length12 Millimeter
Outer Diameter4 Millimeter
Length12 Millimeter
Outer Diameter4 Millimeter
Length12 Millimeter
Outer Diameter4 Millimeter
Length12 Millimeter
Outer Diameter4 Millimeter
Length12 Millimeter
Outer Diameter4 Millimeter
Length12 Millimeter
Outer Diameter4 Millimeter
Length12 Millimeter
Outer Diameter4 Millimeter
Length12 Millimeter
Outer Diameter4 Millimeter
Length12 Millimeter
Outer Diameter4 Millimeter
Length12 Millimeter
Outer Diameter4 Millimeter
Length12 Millimeter
Outer Diameter4 Millimeter
Length12 Millimeter
Outer Diameter4 Millimeter
Length12 Millimeter
Outer Diameter4 Millimeter
Length12 Millimeter
Outer Diameter4 Millimeter
Length12 Millimeter
Outer Diameter4 Millimeter
Length12 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM719GCP2AV40120 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAppliance, Fixation, Spinal Intervertebral Body

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M719GCP2AV40120]

Moist Heat or Steam Sterilization

[M719GCP2AV40120]

Moist Heat or Steam Sterilization

[M719GCP2AV40120]

Moist Heat or Steam Sterilization

[M719GCP2AV40120]

Moist Heat or Steam Sterilization

[M719GCP2AV40120]

Moist Heat or Steam Sterilization

[M719GCP2AV40120]

Moist Heat or Steam Sterilization

[M719GCP2AV40120]

Moist Heat or Steam Sterilization

[M719GCP2AV40120]

Moist Heat or Steam Sterilization

[M719GCP2AV40120]

Moist Heat or Steam Sterilization

[M719GCP2AV40120]

Moist Heat or Steam Sterilization

[M719GCP2AV40120]

Moist Heat or Steam Sterilization

[M719GCP2AV40120]

Moist Heat or Steam Sterilization

[M719GCP2AV40120]

Moist Heat or Steam Sterilization

[M719GCP2AV40120]

Moist Heat or Steam Sterilization

[M719GCP2AV40120]

Moist Heat or Steam Sterilization

[M719GCP2AV40120]

Moist Heat or Steam Sterilization

[M719GCP2AV40120]

Moist Heat or Steam Sterilization

[M719GCP2AV40120]

Moist Heat or Steam Sterilization

[M719GCP2AV40120]

Moist Heat or Steam Sterilization

[M719GCP2AV40120]

Moist Heat or Steam Sterilization

[M719GCP2AV40120]

Moist Heat or Steam Sterilization

[M719GCP2AV40120]

Moist Heat or Steam Sterilization

[M719GCP2AV40120]

Moist Heat or Steam Sterilization

[M719GCP2AV40120]

Moist Heat or Steam Sterilization

[M719GCP2AV40120]

Moist Heat or Steam Sterilization

[M719GCP2AV40120]

Moist Heat or Steam Sterilization

[M719GCP2AV40120]

Moist Heat or Steam Sterilization

[M719GCP2AV40120]

Moist Heat or Steam Sterilization

[M719GCP2AV40120]

Moist Heat or Steam Sterilization

[M719GCP2AV40120]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-07-28
Device Publish Date2023-07-20

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M719GCP2AV401204.00mm x 12mm Binary Auger Tip Variable Screw
M719GCP2AV401004.00mm x 10mm Binary Auger Tip Variable Screw
M719GCP2343043mm 3-Level Binary Cervical Plate
M719GCP2340040mm 3-Level Binary Cervical Plate
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M719GCP2224024mm 2-Level Binary Cervical Plate
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