Lumbar Interbody System GL424-H

GUDID M719GL424H0

Hudson Slide Hammer

Genesys Orthopedics Systems LLC

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Primary Device IDM719GL424H0
NIH Device Record Key9b7753ef-42cd-4bab-b0a2-38805b49da68
Commercial Distribution StatusIn Commercial Distribution
Brand NameLumbar Interbody System
Version Model Number1
Catalog NumberGL424-H
Company DUNS017921066
Company NameGenesys Orthopedics Systems LLC
Device Count1
DM Exempttrue
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

Phone512-381-7070
Emailinfo@genesysspine.com
Phone512-381-7070
Emailinfo@genesysspine.com
Phone512-381-7070
Emailinfo@genesysspine.com
Phone512-381-7070
Emailinfo@genesysspine.com
Phone512-381-7070
Emailinfo@genesysspine.com
Phone512-381-7070
Emailinfo@genesysspine.com
Phone512-381-7070
Emailinfo@genesysspine.com
Phone512-381-7070
Emailinfo@genesysspine.com
Phone512-381-7070
Emailinfo@genesysspine.com
Phone512-381-7070
Emailinfo@genesysspine.com
Phone512-381-7070
Emailinfo@genesysspine.com
Phone512-381-7070
Emailinfo@genesysspine.com
Phone512-381-7070
Emailinfo@genesysspine.com
Phone512-381-7070
Emailinfo@genesysspine.com
Phone512-381-7070
Emailinfo@genesysspine.com
Phone512-381-7070
Emailinfo@genesysspine.com
Phone512-381-7070
Emailinfo@genesysspine.com
Phone512-381-7070
Emailinfo@genesysspine.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM719GL424H0 [Primary]

FDA Product Code

MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M719GL424H0]

Moist Heat or Steam Sterilization

[M719GL424H0]

Moist Heat or Steam Sterilization

[M719GL424H0]

Moist Heat or Steam Sterilization

[M719GL424H0]

Moist Heat or Steam Sterilization

[M719GL424H0]

Moist Heat or Steam Sterilization

[M719GL424H0]

Moist Heat or Steam Sterilization

[M719GL424H0]

Moist Heat or Steam Sterilization

[M719GL424H0]

Moist Heat or Steam Sterilization

[M719GL424H0]

Moist Heat or Steam Sterilization

[M719GL424H0]

Moist Heat or Steam Sterilization

[M719GL424H0]

Moist Heat or Steam Sterilization

[M719GL424H0]

Moist Heat or Steam Sterilization

[M719GL424H0]

Moist Heat or Steam Sterilization

[M719GL424H0]

Moist Heat or Steam Sterilization

[M719GL424H0]

Moist Heat or Steam Sterilization

[M719GL424H0]

Moist Heat or Steam Sterilization

[M719GL424H0]

Moist Heat or Steam Sterilization

[M719GL424H0]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-04-22
Device Publish Date2024-04-12

Devices Manufactured by Genesys Orthopedics Systems LLC

M719GL424H0 - Lumbar Interbody System2024-04-22Hudson Slide Hammer
M719GL424H0 - Lumbar Interbody System2024-04-22 Hudson Slide Hammer
M719GLC7000 - TiLock2 Pedicle Screw System2024-04-22 MIS Arc Distractor Variable Shaft
M719GLL101L0 - 3DP Lumbar Interbody System2024-04-22 LLIF Angled Inserter - Left
M719GLL101R0 - 3DP Lumbar Interbody System2024-04-22 LLIF Angled Inserter - Right
M719GLL102M06000 - 3DP Lumbar Interbody System2024-04-22 LLIF Ingot Trial, Medium 6mm x 0-Degree
M719GLL102M08080 - 3DP Lumbar Interbody System2024-04-22 LLIF Ingot Trial, Medium 8mm x 8-Degree
M719GLL102M08150 - 3DP Lumbar Interbody System2024-04-22 LLIF Ingot Trial, Medium 8mm x 15-Degree
M719GLL102M10080 - 3DP Lumbar Interbody System2024-04-22 LLIF Ingot Trial, Medium 10mm x 8-Degree
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