3DP Lumbar Interbody GLL105

GUDID M719GLL1050

Modular Hudson Connect T-Handle

Genesys Orthopedics Systems LLC

Lumbar total intervertebral disc prosthesis
Primary Device IDM719GLL1050
NIH Device Record Key8c9f4f2d-a57a-4d08-a40b-379506af7750
Commercial Distribution StatusIn Commercial Distribution
Brand Name3DP Lumbar Interbody
Version Model Number1
Catalog NumberGLL105
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

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
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
HIBCCM719GLL1050 [Primary]

FDA Product Code

MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M719GLL1050]

Moist Heat or Steam Sterilization

[M719GLL1050]

Moist Heat or Steam Sterilization

[M719GLL1050]

Moist Heat or Steam Sterilization

[M719GLL1050]

Moist Heat or Steam Sterilization

[M719GLL1050]

Moist Heat or Steam Sterilization

[M719GLL1050]

Moist Heat or Steam Sterilization

[M719GLL1050]

Moist Heat or Steam Sterilization

[M719GLL1050]

Moist Heat or Steam Sterilization

[M719GLL1050]

Moist Heat or Steam Sterilization

[M719GLL1050]

Moist Heat or Steam Sterilization

[M719GLL1050]

Moist Heat or Steam Sterilization

[M719GLL1050]

Moist Heat or Steam Sterilization

[M719GLL1050]

Moist Heat or Steam Sterilization

[M719GLL1050]

Moist Heat or Steam Sterilization

[M719GLL1050]

Moist Heat or Steam Sterilization

[M719GLL1050]

Moist Heat or Steam Sterilization

[M719GLL1050]

Moist Heat or Steam Sterilization

[M719GLL1050]

Moist Heat or Steam Sterilization

[M719GLL1050]

Moist Heat or Steam Sterilization

[M719GLL1050]

Moist Heat or Steam Sterilization

[M719GLL1050]

Moist Heat or Steam Sterilization

[M719GLL1050]

Moist Heat or Steam Sterilization

[M719GLL1050]

Moist Heat or Steam Sterilization

[M719GLL1050]

Moist Heat or Steam Sterilization

[M719GLL1050]

Moist Heat or Steam Sterilization

[M719GLL1050]

Moist Heat or Steam Sterilization

[M719GLL1050]

Moist Heat or Steam Sterilization

[M719GLL1050]

Moist Heat or Steam Sterilization

[M719GLL1050]

Moist Heat or Steam Sterilization

[M719GLL1050]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-11-07
Device Publish Date2024-10-30

Devices Manufactured by Genesys Orthopedics Systems LLC

M719GLL1050 - 3DP Lumbar Interbody2024-11-07Modular Hudson Connect T-Handle
M719GLL1050 - 3DP Lumbar Interbody2024-11-07 Modular Hudson Connect T-Handle
M179GSIX10200 - Sacroiliac Joint Fusion System2024-09-17 SI-X Nav Straight Lenke Probe
M179GSIX10400 - Sacroiliac Joint Fusion System2024-09-17 SI-X Nav Straight Probe
M179GSIX10604500 - Sacroiliac Joint Fusion System2024-09-17 SI-X Nav Awl Tipped Taps 4.5mm
M179GSIX10605500 - Sacroiliac Joint Fusion System2024-09-17 SI-X Nav Awl Tipped Taps 5.5mm shaft
M179GSIX10606500 - Sacroiliac Joint Fusion System2024-09-17 SI-X Nav Awl Tipped Taps 6.5mm shaft
M179GSIX10607500 - Sacroiliac Joint Fusion System2024-09-17 SI-X Nav Awl Tipped Taps 7.5mm shaft
M179GSIX10608500 - Sacroiliac Joint Fusion System2024-09-17 SI-X Nav Awl Tipped Taps 8.5mm shaft
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