Cortera Spinal Fixation System

GUDID 00840311207442

Rod, Ti, Prebent, 6.0x30

Xtant Medical Holdings, Inc.

Bone-screw internal spinal fixation system rod
Primary Device ID00840311207442
NIH Device Record Keyc3a0ecf6-b4af-4d6b-a271-3c0f3ee832d7
Commercial Distribution StatusIn Commercial Distribution
Brand NameCortera Spinal Fixation System
Version Model Number150200-60030
Company DUNS081224143
Company NameXtant Medical Holdings, 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 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(888)886-9354
Emailcs@xtantmedical.com
Phone+1(888)886-9354
Emailcs@xtantmedical.com
Phone+1(888)886-9354
Emailcs@xtantmedical.com
Phone+1(888)886-9354
Emailcs@xtantmedical.com
Phone+1(888)886-9354
Emailcs@xtantmedical.com
Phone+1(888)886-9354
Emailcs@xtantmedical.com
Phone+1(888)886-9354
Emailcs@xtantmedical.com
Phone+1(888)886-9354
Emailcs@xtantmedical.com
Phone+1(888)886-9354
Emailcs@xtantmedical.com
Phone+1(888)886-9354
Emailcs@xtantmedical.com
Phone+1(888)886-9354
Emailcs@xtantmedical.com
Phone+1(888)886-9354
Emailcs@xtantmedical.com
Phone+1(888)886-9354
Emailcs@xtantmedical.com
Phone+1(888)886-9354
Emailcs@xtantmedical.com
Phone+1(888)886-9354
Emailcs@xtantmedical.com
Phone+1(888)886-9354
Emailcs@xtantmedical.com
Phone+1(888)886-9354
Emailcs@xtantmedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100840311207442 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKBThoracolumbosacral pedicle screw system

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840311207442]

Moist Heat or Steam Sterilization

[00840311207442]

Moist Heat or Steam Sterilization

[00840311207442]

Moist Heat or Steam Sterilization

[00840311207442]

Moist Heat or Steam Sterilization

[00840311207442]

Moist Heat or Steam Sterilization

[00840311207442]

Moist Heat or Steam Sterilization

[00840311207442]

Moist Heat or Steam Sterilization

[00840311207442]

Moist Heat or Steam Sterilization

[00840311207442]

Moist Heat or Steam Sterilization

[00840311207442]

Moist Heat or Steam Sterilization

[00840311207442]

Moist Heat or Steam Sterilization

[00840311207442]

Moist Heat or Steam Sterilization

[00840311207442]

Moist Heat or Steam Sterilization

[00840311207442]

Moist Heat or Steam Sterilization

[00840311207442]

Moist Heat or Steam Sterilization

[00840311207442]

Moist Heat or Steam Sterilization

[00840311207442]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-10-17
Device Publish Date2024-10-09

On-Brand Devices [Cortera Spinal Fixation System]

00840311247929CORTERA, 30° ANGLED DEROTATOR
00840311247967ROD INSERTER, MIS, 90DEG, SUB, BODY, MT, SLIM
00840311254453Screw, Poly, Solid, 10.0x20
00840311254446Screw, Poly, Solid, 9.5x20
00840311254439Screw, Poly, Solid, 9.0x20
00840311254422Screw, Poly, Solid, 8.5x20
00840311254415Screw, Poly, Solid, 8.0x20
00840311254408Screw, Poly, Solid, 7.5x20
00840311254392Screw, Poly, Solid, 7.0x20
00840311254385Screw, Poly, Solid, 6.5x20
00840311254378Screw, Poly, Solid, 6.0x20
00840311254361Screw, Poly, Solid, 5.5x20
00840311254354Screw, Poly, Solid, 5.0x20
00840311254347Screw, Poly, Solid, 4.5x20
00840311254330Screw, Poly, Solid, 4.0x20
00840311253685Connector, Lateral Offset, Closed, 90mm
00840311253678Connector, Lateral Offset, Closed, 70mm
00840311253661Connector, Lateral Offset, Closed, 50mm
00840311253654Connector, Lateral Offset, Closed, 30mm
00840311253647Connector, Lateral Offset, Open, 90mm
00840311253630Connector, Lateral Offset, Open, 70mm
00840311253623Connector, Lateral Offset, Open, 30mm
00840311253616Connector, Lateral Offset, Open, 50mm
00840311253487Screw, Poly, MIS, Cann, 12.5x20
00840311253470Screw, Poly, MIS, Cann, 12.0x20
00840311253463Screw, Poly, MIS, Cann, 11.5x20
00840311253456Screw, Poly, MIS, Cann, 10.5x20
00840311253449SCREW, POLY, CANN, 12.5 x 60
00840311253432SCREW, POLY, CANN, 12.5 x 55
00840311253425SCREW, POLY, CANN, 12.5 x 50
00840311253418SCREW, POLY, CANN, 12.5 x 45
00840311253401SCREW, POLY, CANN, 12.5 x 40
00840311253395SCREW, POLY, CANN, 12.5 x 35
00840311253388SCREW, POLY, CANN, 12.5 x 30
00840311253371SCREW, POLY, CANN, 12.5 x 25
00840311253364SCREW, POLY, CANN, 12.5 x 20
00840311253357Screw, Poly, Cann, 12.0x60
00840311253340Screw, Poly, Cann, 12.0x55
00840311253333Screw, Poly, Cann, 12.0x50
00840311253326Screw, Poly, Cann, 12.0x45
00840311253319Screw, Poly, Cann, 12.0x40
00840311253302Screw, Poly, Cann, 12.0x35
00840311253296Screw, Poly, Cann, 12.0x30
00840311253289Screw, Poly, Cann, 12.0x25
00840311253272Screw, Poly, Cann, 12.0x20
00840311253265Screw, Poly, Cann, 11.5x60
00840311253258Screw, Poly, Cann, 11.5x55
00840311253241Screw, Poly, Cann, 11.5x50
00840311253234Screw, Poly, Cann, 11.5x45
00840311253227Screw, Poly, Cann, 11.5x40
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.