FIREBIRD SFS;SFS

GUDID 18257200016440

15MM FIXED CROSS CONNECTOR

ORTHOFIX INC.

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID18257200016440
NIH Device Record Key73075658-76ff-4adf-bf38-bc1f5cfa85b6
Commercial Distribution StatusIn Commercial Distribution
Brand NameFIREBIRD SFS;SFS
Version Model Number57-5315
Company DUNS927083808
Company NameORTHOFIX 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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)527-0404
Emailcustomerservice@orthofix.com
Phone+1(800)527-0404
Emailcustomerservice@orthofix.com
Phone+1(800)527-0404
Emailcustomerservice@orthofix.com
Phone+1(800)527-0404
Emailcustomerservice@orthofix.com
Phone+1(800)527-0404
Emailcustomerservice@orthofix.com
Phone+1(800)527-0404
Emailcustomerservice@orthofix.com
Phone+1(800)527-0404
Emailcustomerservice@orthofix.com
Phone+1(800)527-0404
Emailcustomerservice@orthofix.com
Phone+1(800)527-0404
Emailcustomerservice@orthofix.com
Phone+1(800)527-0404
Emailcustomerservice@orthofix.com
Phone+1(800)527-0404
Emailcustomerservice@orthofix.com
Phone+1(800)527-0404
Emailcustomerservice@orthofix.com
Phone+1(800)527-0404
Emailcustomerservice@orthofix.com
Phone+1(800)527-0404
Emailcustomerservice@orthofix.com
Phone+1(800)527-0404
Emailcustomerservice@orthofix.com
Phone+1(800)527-0404
Emailcustomerservice@orthofix.com
Phone+1(800)527-0404
Emailcustomerservice@orthofix.com
Phone+1(800)527-0404
Emailcustomerservice@orthofix.com

Device Identifiers

Device Issuing AgencyDevice ID
GS118257200016440 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKBThoracolumbosacral pedicle screw system

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[18257200016440]

Moist Heat or Steam Sterilization


[18257200016440]

Moist Heat or Steam Sterilization


[18257200016440]

Moist Heat or Steam Sterilization


[18257200016440]

Moist Heat or Steam Sterilization


[18257200016440]

Moist Heat or Steam Sterilization


[18257200016440]

Moist Heat or Steam Sterilization


[18257200016440]

Moist Heat or Steam Sterilization


[18257200016440]

Moist Heat or Steam Sterilization


[18257200016440]

Moist Heat or Steam Sterilization


[18257200016440]

Moist Heat or Steam Sterilization


[18257200016440]

Moist Heat or Steam Sterilization


[18257200016440]

Moist Heat or Steam Sterilization


[18257200016440]

Moist Heat or Steam Sterilization


[18257200016440]

Moist Heat or Steam Sterilization


[18257200016440]

Moist Heat or Steam Sterilization


[18257200016440]

Moist Heat or Steam Sterilization


[18257200016440]

Moist Heat or Steam Sterilization


[18257200016440]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-03-20
Device Publish Date2019-03-12

On-Brand Devices [FIREBIRD SFS;SFS]

18257200056125ROD ROCKER SFS HOOK SYSTEM
1825720001646419MM FIXED CROSS CONNECTOR
1825720001645717MM FIXED CROSS CONNECTOR
1825720001644015MM FIXED CROSS CONNECTOR

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