HiJAK™ Cervical 1119-02-0013

GUDID M68111190200130

13mm LG Adjustable Lordotic Implant, HiJAK™ Cervical

ATLAS SPINE, INC.

Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage
Primary Device IDM68111190200130
NIH Device Record Key6f2ed406-f7a3-4886-aad3-305bbe11ef67
Commercial Distribution StatusIn Commercial Distribution
Brand NameHiJAK™ Cervical
Version Model NumberHiJAK™ Cervical
Catalog Number1119-02-0013
Company DUNS140801007
Company NameATLAS SPINE, INC.
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(561) 741-1108
Emailsales@atlasspine.com
Phone(561) 741-1108
Emailsales@atlasspine.com
Phone(561) 741-1108
Emailsales@atlasspine.com
Phone(561) 741-1108
Emailsales@atlasspine.com
Phone(561) 741-1108
Emailsales@atlasspine.com
Phone(561) 741-1108
Emailsales@atlasspine.com
Phone(561) 741-1108
Emailsales@atlasspine.com
Phone(561) 741-1108
Emailsales@atlasspine.com
Phone(561) 741-1108
Emailsales@atlasspine.com
Phone(561) 741-1108
Emailsales@atlasspine.com
Phone(561) 741-1108
Emailsales@atlasspine.com
Phone(561) 741-1108
Emailsales@atlasspine.com
Phone(561) 741-1108
Emailsales@atlasspine.com
Phone(561) 741-1108
Emailsales@atlasspine.com
Phone(561) 741-1108
Emailsales@atlasspine.com
Phone(561) 741-1108
Emailsales@atlasspine.com
Phone(561) 741-1108
Emailsales@atlasspine.com
Phone(561) 741-1108
Emailsales@atlasspine.com
Phone(561) 741-1108
Emailsales@atlasspine.com
Phone(561) 741-1108
Emailsales@atlasspine.com
Phone(561) 741-1108
Emailsales@atlasspine.com
Phone(561) 741-1108
Emailsales@atlasspine.com
Phone(561) 741-1108
Emailsales@atlasspine.com
Phone(561) 741-1108
Emailsales@atlasspine.com
Phone(561) 741-1108
Emailsales@atlasspine.com
Phone(561) 741-1108
Emailsales@atlasspine.com
Phone(561) 741-1108
Emailsales@atlasspine.com
Phone(561) 741-1108
Emailsales@atlasspine.com
Phone(561) 741-1108
Emailsales@atlasspine.com
Phone(561) 741-1108
Emailsales@atlasspine.com

Device Dimensions

Height13 Millimeter
Height13 Millimeter
Height13 Millimeter
Height13 Millimeter
Height13 Millimeter
Height13 Millimeter
Height13 Millimeter
Height13 Millimeter
Height13 Millimeter
Height13 Millimeter
Height13 Millimeter
Height13 Millimeter
Height13 Millimeter
Height13 Millimeter
Height13 Millimeter
Height13 Millimeter
Height13 Millimeter
Height13 Millimeter
Height13 Millimeter
Height13 Millimeter
Height13 Millimeter
Height13 Millimeter
Height13 Millimeter
Height13 Millimeter
Height13 Millimeter
Height13 Millimeter
Height13 Millimeter
Height13 Millimeter
Height13 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM68111190200130 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ODPIntervertebral Fusion Device With Bone Graft, Cervical

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M68111190200130]

Moist Heat or Steam Sterilization


[M68111190200130]

Moist Heat or Steam Sterilization


[M68111190200130]

Moist Heat or Steam Sterilization


[M68111190200130]

Moist Heat or Steam Sterilization


[M68111190200130]

Moist Heat or Steam Sterilization


[M68111190200130]

Moist Heat or Steam Sterilization


[M68111190200130]

Moist Heat or Steam Sterilization


[M68111190200130]

Moist Heat or Steam Sterilization


[M68111190200130]

Moist Heat or Steam Sterilization


[M68111190200130]

Moist Heat or Steam Sterilization


[M68111190200130]

Moist Heat or Steam Sterilization


[M68111190200130]

Moist Heat or Steam Sterilization


[M68111190200130]

Moist Heat or Steam Sterilization


[M68111190200130]

Moist Heat or Steam Sterilization


[M68111190200130]

Moist Heat or Steam Sterilization


[M68111190200130]

Moist Heat or Steam Sterilization


[M68111190200130]

Moist Heat or Steam Sterilization


[M68111190200130]

Moist Heat or Steam Sterilization


[M68111190200130]

Moist Heat or Steam Sterilization


[M68111190200130]

Moist Heat or Steam Sterilization


[M68111190200130]

Moist Heat or Steam Sterilization


[M68111190200130]

Moist Heat or Steam Sterilization


[M68111190200130]

Moist Heat or Steam Sterilization


[M68111190200130]

Moist Heat or Steam Sterilization


[M68111190200130]

Moist Heat or Steam Sterilization


[M68111190200130]

Moist Heat or Steam Sterilization


[M68111190200130]

Moist Heat or Steam Sterilization


[M68111190200130]

Moist Heat or Steam Sterilization


[M68111190200130]

Moist Heat or Steam Sterilization


[M68111190200130]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-02-24
Device Publish Date2019-09-30

On-Brand Devices [HiJAK™ Cervical]

M6812019090014014mm LG Lordotic Expanding Trial, HiJAK™ Cervical
M6812019090013013mm LG Lordotic Expanding Trial, HiJAK™ Cervical
M6812019090012012mm LG Lordotic Expanding Trial, HiJAK™ Cervical
M6812019090011011mm LG Lordotic Expanding Trial, HiJAK™ Cervical
M6812019090010010mm LG Lordotic Expanding Trial, HiJAK™ Cervical
M681201909000909mm LG Lordotic Expanding Trial, HiJAK™ Cervical
M681201909000808mm LG Lordotic Expanding Trial, HiJAK™ Cervical
M681201909000707mm LG Lordotic Expanding Trial, HiJAK™ Cervical
M6812019080014014mm LG Lordotic Expanding Trial, HiJAK™ Cervical
M6812019080013013mm LG Lordotic Expanding Trial, HiJAK™ Cervical
M6812019080012012mm LG Lordotic Expanding Trial, HiJAK™ Cervical
M6812019080011011mm LG Lordotic Expanding Trial, HiJAK™ Cervical
M6812019080010010mm LG Lordotic Expanding Trial, HiJAK™ Cervical
M681201908000909mm SM Lordotic Expanding Trial, HiJAK™ Cervical
M681201908000808mm SM Lordotic Expanding Trial, HiJAK™ Cervical
M681201908000707mm SM Lordotic Expanding Trial, HiJAK™ Cervical
M6812019070014014mm LG HL Expanding Trial, HiJAK™ Cervical
M6812019070013013mm LG HL Expanding Trial, HiJAK™ Cervical
M6812019070012012mm LG HL Expanding Trial, HiJAK™ Cervical
M6812019070011011mm LG HL Expanding Trial, HiJAK™ Cervical
M6812019070010010mm LG HL Expanding Trial, HiJAK™ Cervical
M681201907000909mm LG HL Expanding Trial, HiJAK™ Cervical
M681201907000808mm LG HL Expanding Trial, HiJAK™ Cervical
M6812019060014014mm SM HL Expanding Trial, HiJAK™ Cervical
M6812019060013013mm SM HL Expanding Trial, HiJAK™ Cervical
M6812019060012012mm SM HL Expanding Trial, HiJAK™ Cervical
M6812019060011011mm SM HL Expanding Trial, HiJAK™ Cervical
M6812019060010010mm SM HL Expanding Trial, HiJAK™ Cervical
M681201906000909mm SM HL Expanding Trial, HiJAK™ Cervical
M681201906000808mm SM HL Expanding Trial, HiJAK™ Cervical
M6812019050014014mm LG Lordotic Static Trial, HiJAK™ Cervical
M6812019050013013mm LG Lordotic Static Trial, HiJAK™ Cervical
M6812019050012012mm LG Lordotic Static Trial, HiJAK™ Cervical
M6812019050011011mm LG Lordotic Static Trial, HiJAK™ Cervical
M6812019050010010mm LG Lordotic Static Trial, HiJAK™ Cervical
M681201905000909mm LG Lordotic Static Trial, HiJAK™ Cervical
M681201905000808mm LG Lordotic Static Trial, HiJAK™ Cervical
M681201905000707mm LG Lordotic Static Trial, HiJAK™ Cervical
M6812019040014014mm SM Lordotic Static Trial, HiJAK™ Cervical
M6812019040013013mm SM Lordotic Static Trial, HiJAK™ Cervical
M6812019040012012mm SM Lordotic Static Trial, HiJAK™ Cervical
M6812019040011011mm SM Lordotic Static Trial, HiJAK™ Cervical
M6812019040010010mm SM Lordotic Static Trial, HiJAK™ Cervical
M681201904000909mm SM Lordotic Static Trial, HiJAK™ Cervical
M681201904000808mm SM Lordotic Static Trial, HiJAK™ Cervical
M681201904000707mm SM Lordotic Static Trial, HiJAK™ Cervical
M6812019030014014mm LG Hyperlordotic Static Trial, HiJAK™ Cervical
M6812019030013013mm LG Hyperlordotic Static Trial, HiJAK™ Cervical
M6812019030012012mm LG Hyperlordotic Static Trial, HiJAK™ Cervical
M6812019030011011mm LG Hyperlordotic Static Trial, HiJAK™ Cervical

Trademark Results [HiJAK]

Mark Image

Registration | Serial
Company
Trademark
Application Date
HIJAK
HIJAK
88192134 5780714 Live/Registered
Atlas Spine, Inc.
2018-11-13

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