HiJAK™ Stand Alone 1123-02-0014

GUDID M68111230200140

14mm LG FP Lordotic Implant, HiJAK™ Stand Alone

ATLAS SPINE, INC.

Polymeric spinal interbody fusion cage
Primary Device IDM68111230200140
NIH Device Record Key8eb9ff62-2105-409d-82db-c095c6de3220
Commercial Distribution StatusIn Commercial Distribution
Brand NameHiJAK™ Stand Alone
Version Model Number1123-02-0014
Catalog Number1123-02-0014
Company DUNS140801007
Company NameATLAS SPINE, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
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

Device Dimensions

Height14 Millimeter
Height14 Millimeter
Height14 Millimeter
Height14 Millimeter
Height14 Millimeter
Height14 Millimeter
Height14 Millimeter
Height14 Millimeter
Height14 Millimeter
Height14 Millimeter
Height14 Millimeter
Height14 Millimeter
Height14 Millimeter
Height14 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM68111230200140 [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

[M68111230200140]

Moist Heat or Steam Sterilization


[M68111230200140]

Moist Heat or Steam Sterilization


[M68111230200140]

Moist Heat or Steam Sterilization


[M68111230200140]

Moist Heat or Steam Sterilization


[M68111230200140]

Moist Heat or Steam Sterilization


[M68111230200140]

Moist Heat or Steam Sterilization


[M68111230200140]

Moist Heat or Steam Sterilization


[M68111230200140]

Moist Heat or Steam Sterilization


[M68111230200140]

Moist Heat or Steam Sterilization


[M68111230200140]

Moist Heat or Steam Sterilization


[M68111230200140]

Moist Heat or Steam Sterilization


[M68111230200140]

Moist Heat or Steam Sterilization


[M68111230200140]

Moist Heat or Steam Sterilization


[M68111230200140]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-01
Device Publish Date2020-09-23

On-Brand Devices [HiJAK™ Stand Alone]

M6811123040014014mm LG FP HL Implant, HiJAK™ Stand Alone
M6811123040013013mm LG FP HL Implant, HiJAK™ Stand Alone
M6811123040012012mm LG FP HL Implant, HiJAK™ Stand Alone
M6811123040011011mm LG FP HL Implant, HiJAK™ Stand Alone
M6811123040010010mm LG FP HL Implant, HiJAK™ Stand Alone
M681112304000909mm LG FP HL Implant, HiJAK™ Stand Alone
M681112304000808mm LG FP HL Implant, HiJAK™ Stand Alone
M6811123030014014mm SM FP HL Implant, HiJAK™ Stand Alone
M6811123030013013mm SM FP HL Implant, HiJAK™ Stand Alone
M6811123030012012mm SM FP HL Implant, HiJAK™ Stand Alone
M6811123030011011mm SM FP HL Implant, HiJAK™ Stand Alone
M6811123030010010mm SM FP HL Implant, HiJAK™ Stand Alone
M681112303000909mm SM FP HL Implant, HiJAK™ Stand Alone
M681112303000808mm SM FP HL Implant, HiJAK™ Stand Alone
M6811123020014014mm LG FP Lordotic Implant, HiJAK™ Stand Alone
M6811123020013013mm LG FP Lordotic Implant, HiJAK™ Stand Alone
M6811123020012012mm LG FP Lordotic Implant, HiJAK™ Stand Alone
M6811123020011011mm LG FP Lordotic Implant, HiJAK™ Stand Alone
M6811123020010010mm LG FP Lordotic Implant, HiJAK™ Stand Alone
M681112302000909mm LG FP Lordotic Implant, HiJAK™ Stand Alone
M681112302000808mm LG FP Lordotic Implant, HiJAK™ Stand Alone
M681112302000707mm LG FP Lordotic Implant, HiJAK™ Stand Alone
M6811123010014014mm SM FP Lordotic Implant, HiJAK™ Stand Alone
M6811123010013013mm SM FP Lordotic Implant, HiJAK™ Stand Alone
M6811123010012012mm SM FP Lordotic Implant, HiJAK™ Stand Alone
M6811123010011011mm SM FP Lordotic Implant, HiJAK™ Stand Alone
M6811123010010010mm SM FP Lordotic Implant, HiJAK™ Stand Alone
M681112301000909mm SM FP Lordotic Implant, HiJAK™ Stand Alone
M681112301000808mm SM FP Lordotic Implant, HiJAK™ Stand Alone
M681112301000707mm SM FP Lordotic Implant, HiJAK™ Stand Alone

Trademark Results [HiJAK]

Mark Image

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.