Apache Anchored Cervical Interbody Fusion System GCV108-11-L

GUDID M719GCV10811L0

Large 11mm Cervical Rasp

Genesys Orthopedics Systems LLC

Bone file/rasp, manual, reusable
Primary Device IDM719GCV10811L0
NIH Device Record Key96e88265-31b9-481f-93ce-0e0a933b941e
Commercial Distribution StatusIn Commercial Distribution
Brand NameApache Anchored Cervical Interbody Fusion System
Version Model Number1
Catalog NumberGCV108-11-L
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

Device Dimensions

Height11 Millimeter
Height11 Millimeter
Height11 Millimeter
Height11 Millimeter
Height11 Millimeter
Height11 Millimeter
Height11 Millimeter
Height11 Millimeter
Height11 Millimeter
Height11 Millimeter
Height11 Millimeter
Height11 Millimeter
Height11 Millimeter
Height11 Millimeter
Height11 Millimeter
Height11 Millimeter
Height11 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM719GCV10811L0 [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

[M719GCV10811L0]

Moist Heat or Steam Sterilization

[M719GCV10811L0]

Moist Heat or Steam Sterilization

[M719GCV10811L0]

Moist Heat or Steam Sterilization

[M719GCV10811L0]

Moist Heat or Steam Sterilization

[M719GCV10811L0]

Moist Heat or Steam Sterilization

[M719GCV10811L0]

Moist Heat or Steam Sterilization

[M719GCV10811L0]

Moist Heat or Steam Sterilization

[M719GCV10811L0]

Moist Heat or Steam Sterilization

[M719GCV10811L0]

Moist Heat or Steam Sterilization

[M719GCV10811L0]

Moist Heat or Steam Sterilization

[M719GCV10811L0]

Moist Heat or Steam Sterilization

[M719GCV10811L0]

Moist Heat or Steam Sterilization

[M719GCV10811L0]

Moist Heat or Steam Sterilization

[M719GCV10811L0]

Moist Heat or Steam Sterilization

[M719GCV10811L0]

Moist Heat or Steam Sterilization

[M719GCV10811L0]

Moist Heat or Steam Sterilization

[M719GCV10811L0]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-07-28
Device Publish Date2023-07-20

On-Brand Devices [Apache Anchored Cervical Interbody Fusion System]

M719GCV10905L05mm Large Cervical Trial
M719GCV10811L0Large 11mm Cervical Rasp
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