Cortera

GUDID 00840311207879

Rod, Ti, MIS Prebent, 5.5x80

Surgalign Spine Technologies, Inc.

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00840311207879
NIH Device Record Key792e3264-07f8-4717-8a95-17e389b4104f
Commercial Distribution StatusIn Commercial Distribution
Brand NameCortera
Version Model Number150203-55080
Company DUNS014520584
Company NameSurgalign Spine Technologies, Inc.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
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

Phone+1(844)894-7752
Emailcustomerservice@surgalign.com
Phone+1(844)894-7752
Emailcustomerservice@surgalign.com
Phone+1(844)894-7752
Emailcustomerservice@surgalign.com
Phone+1(844)894-7752
Emailcustomerservice@surgalign.com
Phone+1(844)894-7752
Emailcustomerservice@surgalign.com
Phone+1(844)894-7752
Emailcustomerservice@surgalign.com
Phone+1(844)894-7752
Emailcustomerservice@surgalign.com
Phone+1(844)894-7752
Emailcustomerservice@surgalign.com
Phone+1(844)894-7752
Emailcustomerservice@surgalign.com
Phone+1(844)894-7752
Emailcustomerservice@surgalign.com
Phone+1(844)894-7752
Emailcustomerservice@surgalign.com
Phone+1(844)894-7752
Emailcustomerservice@surgalign.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100840311207879 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKBThoracolumbosacral pedicle screw system

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840311207879]

Moist Heat or Steam Sterilization


[00840311207879]

Moist Heat or Steam Sterilization


[00840311207879]

Moist Heat or Steam Sterilization


[00840311207879]

Moist Heat or Steam Sterilization


[00840311207879]

Moist Heat or Steam Sterilization


[00840311207879]

Moist Heat or Steam Sterilization


[00840311207879]

Moist Heat or Steam Sterilization


[00840311207879]

Moist Heat or Steam Sterilization


[00840311207879]

Moist Heat or Steam Sterilization


[00840311207879]

Moist Heat or Steam Sterilization


[00840311207879]

Moist Heat or Steam Sterilization


[00840311207879]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-12
Device Publish Date2023-06-02

On-Brand Devices [Cortera]

00840311209095Guidewire, Nitinol, Blunt Tip, 350
00840311232222Reducer, Open Inline, Reduction Pusher
00840311232215Reducer, Open Inline
00840311211012Reducer, MIS Threaded, SUB, Body
00840311211005Reducer, MIS Threaded, SUB, Shaft
00840311240968Probe, NAV, Lenke, Iliac, Straight
00840311234196Tap, NAV, Iliac, Solid, 12.5
00840311234189Tap, NAV, Iliac, Solid, 11.5
00840311234172Tap, NAV, Iliac, Solid, 10.5
00840311234165Tap, NAV, Iliac, Solid, 9.5
00840311234158Tap, NAV, Iliac, Solid, 8.5
00840311234141Tap, NAV, Iliac, Solid, 8.0
00840311234134Tap, NAV, Iliac, Solid, 7.5
00840311234127Tap, NAV, Iliac, Solid, 7.0
00840311234110Tap, NAV, Iliac, Solid, 6.5
00840311234103Tap, NAV, Iliac, Solid, 6.0
00840311234097Tap, NAV, Iliac, Solid, 5.5
00840311234080Tap, NAV, Iliac, Solid, 5.0
00840311234073Tap, NAV, Iliac, Solid, 4.5
00840311234066Tap, NAV, Iliac, Solid, 4.0
00840311234059Tap, NAV, Open Cann, 12.5
00840311234042Tap, NAV, Open Cann, 11.5
00840311234035Tap, NAV, Open Cann, 10.5
00840311234028Tap, NAV, Open Cann, 9.5
00840311234011Tap, NAV, Open Cann, 8.5
00840311234004Tap, NAV, Open Cann, 8.0
00840311233991Tap, NAV, Open Cann, 7.5
00840311233984Tap, NAV, Open Cann, 7.0
00840311233977Tap, NAV, Open Cann, 6.5
00840311233960Tap, NAV, Open Cann, 6.0
00840311233953Tap, NAV, Open Cann, 5.5
00840311233946Tap, NAV, Open Cann, 5.0
00840311233939Tap, NAV, Open Cann, 4.5
00840311233922Tap, NAV, Open Cann, 4.0
00840311233526Tap, NAV, Cann, 12.5
00840311233519Tap, NAV, Cann, 11.5
00840311233502Tap, NAV, Cann, 10.5
00840311233496Tap, NAV, Cann, 9.5
00840311233489Tap, NAV, Cann, 8.5
00840311233472Tap, NAV, Cann, 8.0
00840311233465Tap, NAV, Cann, 7.5
00840311233458Tap, NAV, Cann, 7.0
00840311233441Tap, NAV, Cann, 6.5
00840311233434Tap, NAV, Cann, 6.0
00840311233427Tap, NAV, Cann, 5.5
00840311233410Tap, NAV, Cann, 5.0
00840311233403Tap, NAV, Cann, 4.5
00840311233397Tap, NAV, Cann, 4.0
00840311233380Tap, NAV, Solid, 12.5
00840311233373Tap, NAV, Solid, 11.5

Trademark Results [Cortera]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CORTERA
CORTERA
97274929 not registered Live/Pending
Surgalign Spine Technologies, Inc.
2022-02-18
CORTERA
CORTERA
77409043 3737588 Live/Registered
CORTERA, INC.
2008-02-28

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