3DP Lumbar Interbody System GP531-4

GUDID M719GP53140

16in 4mm Kerrison Rongeur

Genesys Orthopedics Systems LLC

Spinal rongeur Spinal rongeur Spinal rongeur Spinal rongeur Spinal rongeur Spinal rongeur Spinal rongeur Spinal rongeur Spinal rongeur Spinal rongeur Spinal rongeur Spinal rongeur Spinal rongeur Spinal rongeur Spinal rongeur
Primary Device IDM719GP53140
NIH Device Record Key09c8db63-3ff2-4de6-bd04-1df21678405b
Commercial Distribution StatusIn Commercial Distribution
Brand Name3DP Lumbar Interbody System
Version Model Number1
Catalog NumberGP531-4
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 Usefalse
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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM719GP53140 [Primary]
HIBCCM719GP53140 [Primary]
HIBCCM719GP53140 [Primary]
HIBCCM719GP53140 [Primary]
HIBCCM719GP53140 [Primary]
HIBCCM719GP53140 [Primary]
HIBCCM719GP53140 [Primary]
HIBCCM719GP53140 [Primary]
HIBCCM719GP53140 [Primary]
HIBCCM719GP53140 [Primary]
HIBCCM719GP53140 [Primary]
HIBCCM719GP53140 [Primary]
HIBCCM719GP53140 [Primary]
HIBCCM719GP53140 [Primary]
HIBCCM719GP53140 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HTXRongeur
HTXRongeur
HTXRongeur
HTXRongeur
HTXRongeur
HTXRongeur
HTXRongeur
HTXRongeur
HTXRongeur
HTXRongeur
HTXRongeur
HTXRongeur
HTXRongeur
HTXRongeur
HTXRongeur

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M719GP53140]

Moist Heat or Steam Sterilization


[M719GP53140]

Moist Heat or Steam Sterilization


[M719GP53140]

Moist Heat or Steam Sterilization


[M719GP53140]

Moist Heat or Steam Sterilization


[M719GP53140]

Moist Heat or Steam Sterilization


[M719GP53140]

Moist Heat or Steam Sterilization


[M719GP53140]

Moist Heat or Steam Sterilization


[M719GP53140]

Moist Heat or Steam Sterilization


[M719GP53140]

Moist Heat or Steam Sterilization


[M719GP53140]

Moist Heat or Steam Sterilization


[M719GP53140]

Moist Heat or Steam Sterilization


[M719GP53140]

Moist Heat or Steam Sterilization


[M719GP53140]

Moist Heat or Steam Sterilization


[M719GP53140]

Moist Heat or Steam Sterilization


[M719GP53140]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-16
Device Publish Date2020-10-08

On-Brand Devices [3DP Lumbar Interbody System]

M719GL3DS1840P0Small Parallel LLIF - 18mm x 40mm
M719GL3DS1835P0Small Parallel LLIF - 18mm x 35mm
M719GL3DS1830P0Small Parallel LLIF - 18mm x 30mm
M719GL3DS1825P0Small Parallel LLIF - 18mm x 25mm
M719GL3DS1660P0Small Parallel LLIF - 16mm x 60mm
M719GL3DS1655P0Small Parallel LLIF - 16mm x 55mm
M719GL3DS1650P0Small Parallel LLIF - 16mm x 50mm
M719GL3DS1645P0Small Parallel LLIF - 16mm x 45mm
M719GL3DS1640P0Small Parallel LLIF - 16mm x 40mm
M719GL3DS1635P0Small Parallel LLIF - 16mm x 35mm
M719GL3DS1630P0Small Parallel LLIF - 16mm x 30mm
M719GL3DS1625P0Small Parallel LLIF - 16mm x 25mm
M719GL3DS1460P0Small Parallel LLIF - 14mm x 60mm
M719GL3DS1455P0Small Parallel LLIF - 14mm x 55mm
M719GL3DS1450P0Small Parallel LLIF - 14mm x 50mm
M719GL3DS1445P0Small Parallel LLIF - 14mm x 45mm
M719GL3DS1440P0Small Parallel LLIF - 14mm x 40mm
M719GL3DS1435P0Small Parallel LLIF - 14mm x 35mm
M719GL3DS1430P0Small Parallel LLIF - 14mm x 30mm
M719GL3DS1425P0Small Parallel LLIF - 14mm x 25mm
M719GL3DS1260P0Small Parallel LLIF - 12mm x 60mm
M719GL3DS1255P0Small Parallel LLIF - 12mm x 55mm
M719GL3DS1250P0Small Parallel LLIF - 12mm x 50mm
M719GL3DS1245P0Small Parallel LLIF - 12mm x 45mm
M719GL3DS1240P0Small Parallel LLIF - 12mm x 40mm
M719GL3DS1235P0Small Parallel LLIF - 12mm x 35mm
M719GL3DS1230P0Small Parallel LLIF - 12mm x 30mm
M719GL3DS1225P0Small Parallel LLIF - 12mm x 25mm
M719GL3DS1060P0Small Parallel LLIF - 10mm x 60mm
M719GL3DS1055P0Small Parallel LLIF - 10mm x 55mm
M719GL3DS1050P0Small Parallel LLIF - 10mm x 50mm
M719GL3DS1045P0Small Parallel LLIF - 10mm x 45mm
M719GL3DS1040P0Small Parallel LLIF - 10mm x 40mm
M719GL3DS1035P0Small Parallel LLIF - 10mm x 35mm
M719GL3DS1030P0Small Parallel LLIF - 10mm x 30mm
M719GL3DS1025P0Small Parallel LLIF - 10mm x 25mm
M719GHA3D2030S0Small Hyperlordotic 3DP ALIF 20mm x 30 degree
M719GHA3D2030M0Medium Hyperlordotic 3DP ALIF 20mm x 30 degree
M719GHA3D2030L0Large Hyperlordotic 3DP ALIF 20mm x 30 degree
M719GHA3D2024S0Small Hyperlordotic 3DP ALIF 20mm x 24 degree
M719GHA3D2024M0Medium Hyperlordotic 3DP ALIF 20mm x 24 degree
M719GHA3D2024L0Large Hyperlordotic 3DP ALIF 20mm x 24 degree
M719GHA3D2018S0Small Hyperlordotic 3DP ALIF 20mm x 18 degree
M719GHA3D2018M0Medium Hyperlordotic 3DP ALIF 20mm x 18 degree
M719GHA3D2018L0Large Hyperlordotic 3DP ALIF 20mm x 18 degree
M719GHA3D1830S0Small Hyperlordotic 3DP ALIF 18mm x 30 degree
M719GHA3D1830M0Medium Hyperlordotic 3DP ALIF 18mm x 30 degree
M719GHA3D1824S0Small Hyperlordotic 3DP ALIF 18mm x 24 degree
M719GHA3D1824M0Medium Hyperlordotic 3DP ALIF 18mm x 24 degree
M719GHA3D1824L0Large Hyperlordotic 3DP ALIF 18mm x 24 degree

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