AIS-C II ACC106

GUDID M719ACC1060

AIS-C II Impaction Inserter, Threaded

Genesys Orthopedics Systems LLC

Orthopaedic implant inserter/extractor, reusable
Primary Device IDM719ACC1060
NIH Device Record Keya5b1778c-76a6-43e2-962b-6c75ad57c7cb
Commercial Distribution StatusIn Commercial Distribution
Brand NameAIS-C II
Version Model Number1
Catalog NumberACC106
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
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 Identifiers

Device Issuing AgencyDevice ID
HIBCCM719ACC1060 [Primary]

FDA Product Code

OVEIntervertebral Fusion Device With Integrated Fixation, Cervical

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M719ACC1060]

Moist Heat or Steam Sterilization


[M719ACC1060]

Moist Heat or Steam Sterilization


[M719ACC1060]

Moist Heat or Steam Sterilization


[M719ACC1060]

Moist Heat or Steam Sterilization


[M719ACC1060]

Moist Heat or Steam Sterilization


[M719ACC1060]

Moist Heat or Steam Sterilization


[M719ACC1060]

Moist Heat or Steam Sterilization


[M719ACC1060]

Moist Heat or Steam Sterilization


[M719ACC1060]

Moist Heat or Steam Sterilization


[M719ACC1060]

Moist Heat or Steam Sterilization


[M719ACC1060]

Moist Heat or Steam Sterilization


[M719ACC1060]

Moist Heat or Steam Sterilization


[M719ACC1060]

Moist Heat or Steam Sterilization


[M719ACC1060]

Moist Heat or Steam Sterilization


[M719ACC1060]

Moist Heat or Steam Sterilization


[M719ACC1060]

Moist Heat or Steam Sterilization


[M719ACC1060]

Moist Heat or Steam Sterilization


[M719ACC1060]

Moist Heat or Steam Sterilization


[M719ACC1060]

Moist Heat or Steam Sterilization


[M719ACC1060]

Moist Heat or Steam Sterilization


[M719ACC1060]

Moist Heat or Steam Sterilization


[M719ACC1060]

Moist Heat or Steam Sterilization


[M719ACC1060]

Moist Heat or Steam Sterilization


[M719ACC1060]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-03-12
Device Publish Date2024-03-04

On-Brand Devices [AIS-C II]

M719ACC1060AIS-C II Impaction Inserter, Threaded
M719ACC1050AIS-C II Impaction Inserter
M719ACC1040AIS-C II Gun Inserter
M719ACC1030AIS-C II Anchor Extractor

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