3DP Cervical Interbody System GC3-THS-L09

GUDID M719GC3THSL090

Large 9mm 3DP Cervical Trial with Handle

Genesys Orthopedics Systems LLC

Spinal implant trial
Primary Device IDM719GC3THSL090
NIH Device Record Keyfa34dbcc-2f18-40f9-aada-ad9d025f37b0
Commercial Distribution StatusIn Commercial Distribution
Brand Name3DP Cervical Interbody System
Version Model Number1
Catalog NumberGC3-THS-L09
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

Device Dimensions

Height9 Millimeter
Height9 Millimeter
Height9 Millimeter
Height9 Millimeter
Height9 Millimeter
Height9 Millimeter
Height9 Millimeter
Height9 Millimeter
Height9 Millimeter
Height9 Millimeter
Height9 Millimeter
Height9 Millimeter
Height9 Millimeter
Height9 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM719GC3THSL090 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OVEIntervertebral Fusion Device With Integrated Fixation, Cervical

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M719GC3THSL090]

Moist Heat or Steam Sterilization


[M719GC3THSL090]

Moist Heat or Steam Sterilization


[M719GC3THSL090]

Moist Heat or Steam Sterilization


[M719GC3THSL090]

Moist Heat or Steam Sterilization


[M719GC3THSL090]

Moist Heat or Steam Sterilization


[M719GC3THSL090]

Moist Heat or Steam Sterilization


[M719GC3THSL090]

Moist Heat or Steam Sterilization


[M719GC3THSL090]

Moist Heat or Steam Sterilization


[M719GC3THSL090]

Moist Heat or Steam Sterilization


[M719GC3THSL090]

Moist Heat or Steam Sterilization


[M719GC3THSL090]

Moist Heat or Steam Sterilization


[M719GC3THSL090]

Moist Heat or Steam Sterilization


[M719GC3THSL090]

Moist Heat or Steam Sterilization


[M719GC3THSL090]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-07
Device Publish Date2020-09-29

On-Brand Devices [3DP Cervical Interbody System]

M719GCP3D12S012mm 3DP Cervical Interbody, Small, Parallel
M719GCP3D12L012mm 3DP Cervical Interbody, Large, Parallel
M719GCP3D11S011mm 3DP Cervical Interbody, Small, Parallel
M719GCP3D11L011mm 3DP Cervical Interbody, Large, Parallel
M719GCP3D10S010mm 3DP Cervical Interbody, Small, Parallel
M719GCP3D10L010mm 3DP Cervical Interbody, Large, Parallel
M719GCP3D09S09mm 3DP Cervical Interbody, Small, Parallel
M719GCP3D09L09mm 3DP Cervical Interbody, Large, Parallel
M719GCP3D08S08mm 3DP Cervical Interbody, Small, Parallel
M719GCP3D08L08mm 3DP Cervical Interbody, Large, Parallel
M719GCP3D07S07mm 3DP Cervical Interbody, Small, Parallel
M719GCP3D07L07mm 3DP Cervical Interbody, Large, Parallel
M719GCP3D06S06mm 3DP Cervical Interbody, Small, Parallel
M719GCP3D06L06mm 3DP Cervical Interbody, Large, Parallel
M719GCP3D05S05mm 3DP Cervical Interbody, Small, Parallel
M719GCP3D05L05mm 3DP Cervical Interbody, Large, Parallel
M719GCL3D12S012mm 3DP Cervical Interbody, Small, Parallel
M719GCL3D12L012mm 3DP Cervical Interbody, Large, Lordotic
M719GCL3D11S011mm 3DP Cervical Interbody, Small, Lordotic
M719GCL3D11L011mm 3DP Cervical Interbody, Large, Lordotic
M719GCL3D10S010mm 3DP Cervical Interbody, Small, Lordotic
M719GCL3D10L010mm 3DP Cervical Interbody, Large, Lordotic
M719GCL3D09S09mm 3DP Cervical Interbody, Small, Lordotic
M719GCL3D09L09mm 3DP Cervical Interbody, Large, Lordotic
M719GCL3D08S08mm 3DP Cervical Interbody, Small, Lordotic
M719GCL3D08L08mm 3DP Cervical Interbody, Large, Lordotic
M719GCL3D07S07mm Cervical Interbody, Small, Lordotic
M719GCL3D07L07mm 3DP Cervical Interbody, Large, Lordotic
M719GCL3D06S06mm 3DP Cervical Interbody, Small, Lordotic
M719GCL3D06L06mm 3DP Cervical Interbody, Large, Lordotic
M719GCL3D05S05mm 3DP Cervical, Small, Lordotic
M719GCL3D05L05mm 3DP Cervical Interbody, Large, Lordotic
M719GCC3D11S011mm 3DP Cervical Interbody, Small, Convex
M719GCC3D10S010mm 3DP Cervical Interbody, Small, Convex
M719GCC3D09S09mm 3DP Cervical Interbody, Small, Convex
M719GCC3D08S08mm 3DP Cervical Interbody, Small, Convex
M719GCC3D07S07mm 3DP Cervical Interbody, Small, Convex
M719GCC3D06S06mm 3DP Cervical Interbody, Small, Convex
M719GCC3D12S012mm 3DP Cervical Interbody, Small, Convex
M719GCC3D12L012mm 3DP Cervical Interbody, Large, Convex
M719GCC3D11L011mm 3DP Cervical Interbody, Large, Convex
M719GCC3D10L010mm 3DP Cervical Interbody, Large, Convex
M719GCC3D09L09mm 3DP Cervical Interbody, Large, Convex
M719GCC3D08L08mm 3DP Cervical Interbody, Large, Convex
M719GCC3D07L07mm 3DP Cervical Interbody, Large, Convex
M719GCC3D06L06mm 3DP Cervical Interbody, Large, Convex
M719GAC3D12SP012mm 3DP Stand-Alone Cervical Interbody, Small, Parallel
M719GAC3D12SL012mm 3DP Stand-Alone Cervical Interbody, Small, Lordotic
M719GAC3D12LP012mm 3DP Stand-Alone Cervical Interbody, Large, Parallel
M719GAC3D12LL012mm 3DP Stand-Alone Cervical Interbody, Large, Lordotic

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