Apache AIS-C Standalone G4507

GUDID M719G45070

AIS-C Inserter Caddy

Genesys Orthopedics Systems LLC

Surgical instrument/implant rack Surgical instrument/implant rack Surgical instrument/implant rack Surgical instrument/implant rack Surgical instrument/implant rack Surgical instrument/implant rack Surgical instrument/implant rack Surgical instrument/implant rack Surgical instrument/implant rack Surgical instrument/implant rack Surgical instrument/implant rack Surgical instrument/implant rack Surgical instrument/implant rack Surgical instrument/implant rack Surgical instrument/implant rack Surgical instrument/implant rack Surgical instrument/implant rack
Primary Device IDM719G45070
NIH Device Record Key53c3455f-516d-4e31-9ba6-eaaf7a7daa2b
Commercial Distribution StatusIn Commercial Distribution
Brand NameApache AIS-C Standalone
Version Model Number1
Catalog NumberG4507
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 Identifiers

Device Issuing AgencyDevice ID
HIBCCM719G45070 [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

[M719G45070]

Moist Heat or Steam Sterilization

[M719G45070]

Moist Heat or Steam Sterilization

[M719G45070]

Moist Heat or Steam Sterilization

[M719G45070]

Moist Heat or Steam Sterilization

[M719G45070]

Moist Heat or Steam Sterilization

[M719G45070]

Moist Heat or Steam Sterilization

[M719G45070]

Moist Heat or Steam Sterilization

[M719G45070]

Moist Heat or Steam Sterilization

[M719G45070]

Moist Heat or Steam Sterilization

[M719G45070]

Moist Heat or Steam Sterilization

[M719G45070]

Moist Heat or Steam Sterilization

[M719G45070]

Moist Heat or Steam Sterilization

[M719G45070]

Moist Heat or Steam Sterilization

[M719G45070]

Moist Heat or Steam Sterilization

[M719G45070]

Moist Heat or Steam Sterilization

[M719G45070]

Moist Heat or Steam Sterilization

[M719G45070]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-10-01
Device Publish Date2021-09-23

On-Brand Devices [Apache AIS-C Standalone]

M719GAC119N0No Stop AIS-C SS Inserter Tip
M719GAC119404mm AIS-C SS Inserter Tip
M719GAC119303mm AIS-C SS Inserter Tip
M719GAC119202mm AIS-C SS Inserter Tip
M719GAC119101mm AIS-C SS Inserter Tip
M719GAC111SN0No Stop AIS-C Impaction Inserter Cartridge, Small
M719GAC111S404mm AIS-C Impaction Inserter Cartridge Tip, Small
M719GAC111S303mm AIS-C Impaction Inserter Cartridge Tip, Small
M719GAC111S202mm AIS-C Impaction Inserter Cartridge Tip, Small
M719GAC111S101mm AIS-C Impaction Inserter Cartridge Tip, Small
M719GAC111N0No Stop AIS-C Impaction Inserter Cartridge Tip, Hybrid
M719GAC111LN0No Stop AIS-C Impaction Inserter Cartridge Tip, Large
M719GAC111L404mm AIS-C Impaction Inserter Cartridge Tip, Large
M719GAC111L303mm AIS-C Impaction Inserter Cartridge Tip, Large
M719GAC111L202mm AIS-C Impaction Inserter Cartridge Tip, Large
M719GAC111L101mm AIS-C Impaction Inserter Cartridge Tip, Large
M719GAC111404mm AIS-C Impaction Inserter Cartridge Tip, Hybrid
M719GAC110W40Welded Standalone Impaction Inserter - 4mm Stop
M719GAC110W30Welded Standalone Impaction Inserter - 3mm Stop
M719GAC110W20Welded Standalone Impaction Inserter - 2mm Stop
M719GAC110W10Welded Standalone Impaction Inserter - 1mm Stop
M719GAC110TWN0Welded Standalone Impaction Inserter - Threaded, No Stop
M719GAC110TW40Welded Standalone Impaction Inserter - Threaded, 4mm Stop
M719GAC110TW30Welded Standalone Impaction Inserter - Threaded, 3mm Stop
M719GAC110TW20Welded Standalone Impaction Inserter - Threaded, 2mm Stop
M719GAC110TW10Welded Standalone Impaction Inserter - Threaded, 1mm Stop
M719GAC1101N0Welded Standalone Impaction Inserter - No Stop
M719G45080AIS-C Inserter Caddy Lid
M719G45070AIS-C Inserter Caddy
M719G45060AIS-C Tray
M719G45050Apache Anchored Cervical Lid
M719G45040Apache Anchored Cervical Case
M719G45030Nail Caddy Lid
M719G45020Nail Caddy
M719G45010Interbody Caddies Lid
M719G4500U0Interbody Caddy, Universal
M719G45000PEEK Implant Caddy
M719GAC30012012mm Lordotic Cervical Double Trial
M719GAC30011011mm Lordotic Cervical Double Trial
M719GAC30010010mm Lordotic Cervical Double Trial
M719GAC3000909mm Lordotic Cervical Double Trial
M719GAC3000808mm Lordotic Cervical Double Trial
M719GAC3000707mm Lordotic Cervical Double Trial
M719GAC3000606mm Lordotic Cervical Double Trial
M719GAC3000505mm Lordotic Cervical Double Trial
M719GAC111000mm AIS-C Impaction Inserter Cartridge Tip, Hybrid
M719G50150Additional Cervical Plate Caddy Lid
M719G50140Additional Cervical Plate Caddy
M719G45160Standalone Accessory Caddy Lid
M719G45150Standalone Accessory Caddy
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