Genesys Spine Apache® Interbody Fusion System GP734-12

GUDID M719GP734120

12mm X 34mm 3DP Parallel TPLIF Ingot Trial

Genesys Orthopedics Systems LLC

Spinal implant trial
Primary Device IDM719GP734120
NIH Device Record Keye586411b-7df9-4db7-bff9-289ce7015740
Commercial Distribution StatusIn Commercial Distribution
Brand NameGenesys Spine Apache® Interbody Fusion System
Version Model Number1
Catalog NumberGP734-12
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
Phone5123817070
Emailinfo@genesysspine.com
Phone5123817070
Emailinfo@genesysspine.com

Device Dimensions

Length34 Millimeter
Width12 Millimeter
Length34 Millimeter
Width12 Millimeter
Length34 Millimeter
Width12 Millimeter
Length34 Millimeter
Width12 Millimeter
Length34 Millimeter
Width12 Millimeter
Length34 Millimeter
Width12 Millimeter
Length34 Millimeter
Width12 Millimeter
Length34 Millimeter
Width12 Millimeter
Length34 Millimeter
Width12 Millimeter
Length34 Millimeter
Width12 Millimeter
Length34 Millimeter
Width12 Millimeter
Length34 Millimeter
Width12 Millimeter
Length34 Millimeter
Width12 Millimeter
Length34 Millimeter
Width12 Millimeter
Length34 Millimeter
Width12 Millimeter
Length34 Millimeter
Width12 Millimeter
Length34 Millimeter
Width12 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM719GP734120 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M719GP734120]

Moist Heat or Steam Sterilization

[M719GP734120]

Moist Heat or Steam Sterilization

[M719GP734120]

Moist Heat or Steam Sterilization

[M719GP734120]

Moist Heat or Steam Sterilization

[M719GP734120]

Moist Heat or Steam Sterilization

[M719GP734120]

Moist Heat or Steam Sterilization

[M719GP734120]

Moist Heat or Steam Sterilization

[M719GP734120]

Moist Heat or Steam Sterilization

[M719GP734120]

Moist Heat or Steam Sterilization

[M719GP734120]

Moist Heat or Steam Sterilization

[M719GP734120]

Moist Heat or Steam Sterilization

[M719GP734120]

Moist Heat or Steam Sterilization

[M719GP734120]

Moist Heat or Steam Sterilization

[M719GP734120]

Moist Heat or Steam Sterilization

[M719GP734120]

Moist Heat or Steam Sterilization

[M719GP734120]

Moist Heat or Steam Sterilization

[M719GP734120]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-08-01
Device Publish Date2023-07-24

On-Brand Devices [Genesys Spine Apache® Interbody Fusion System]

M719GPH1418M014mm x 18 DEG Hyperlordotic Medium ALIF Trial
M719GP73415015mm X 34mm 3DP Parallel TPLIF Ingot Trial
M719GP73414014mm X 34mm 3DP Parallel TPLIF Ingot Trial
M719GP73413013mm X 34mm 3DP Parallel TPLIF Ingot Trial
M719GP73412012mm X 34mm 3DP Parallel TPLIF Ingot Trial
M719GP73411011mm X 34mm 3DP Parallel TPLIF Ingot Trial
M719GP73410010mm X 34mm 3DP Parallel TPLIF Ingot Trial
M719GP7340909mm X 34mm 3DP Parallel TPLIF Ingot Trial
M719GP7340808mm X 34mm 3DP Parallel TPLIF Ingot Trial
M719GP7340707mm X 34mm 3DP Parallel TPLIF Ingot Trial
M719GP73215015mm X 32mm 3DP Parallel TPLIF Ingot Trial
M719GP73214014mm X 32mm 3DP Parallel TPLIF Ingot Trial
M719GP73213013mm X 32mm 3DP Parallel TPLIF Ingot Trial
M719GP73212012mm X 32mm 3DP Parallel TPLIF Ingot Trial
M719GP73211011mm X 32mm 3DP Parallel TPLIF Ingot Trial
M719GP73210010mm X 32mm 3DP Parallel TPLIF Ingot Trial
M719GP7320909mm X 32mm 3DP Parallel TPLIF Ingot Trial
M719GP7320808mm X 32mm 3DP Parallel TPLIF Ingot Trial
M719GP7320707mm X 32mm 3DP Parallel TPLIF Ingot Trial
M719GP7050Small Silicone Handle
M719GP631140Cervical Star Trial - 14mm
M719GP631120Cervical Star Trial - 12mm
M719GP630140Cervical Star Rasp - 14mm
M719GP630120Cervical Star Rasp - 12mm
M719GP5386012in 6mm 40° Fwd Anterior Kerrison Rongeur
M719GP5384012in 4mm 40° Fwd Anterior Kerrison Rongeur
M719GP5370ALIF Rasp
M719GP5326012in Pituitary Rongeur - 6mm Bite
M719GP51404mm Straight Pituitary Rongeur
M719G30170ALIF Accessory Caddy Lid
M719G30160ALIF Accessory Caddy
M719G30150Hyperlordotic ALIF Caddy Lid
M719G30140Hyperlordotic ALIF Caddy
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