FIREBIRD NXG

GUDID 18257200111572

LOW PROFILE OFFSET, 8MM

ORTHOFIX INC.

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID18257200111572
NIH Device Record Keyc5a720a0-4cf7-4f5c-be0a-1f5a37a4afd2
Commercial Distribution StatusIn Commercial Distribution
Brand NameFIREBIRD NXG
Version Model Number36-6408
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
GS118257200111572 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKBThoracolumbosacral pedicle screw system

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[18257200111572]

Moist Heat or Steam Sterilization

[18257200111572]

Moist Heat or Steam Sterilization

[18257200111572]

Moist Heat or Steam Sterilization

[18257200111572]

Moist Heat or Steam Sterilization

[18257200111572]

Moist Heat or Steam Sterilization

[18257200111572]

Moist Heat or Steam Sterilization

[18257200111572]

Moist Heat or Steam Sterilization

[18257200111572]

Moist Heat or Steam Sterilization

[18257200111572]

Moist Heat or Steam Sterilization

[18257200111572]

Moist Heat or Steam Sterilization

[18257200111572]

Moist Heat or Steam Sterilization

[18257200111572]

Moist Heat or Steam Sterilization

[18257200111572]

Moist Heat or Steam Sterilization

[18257200111572]

Moist Heat or Steam Sterilization

[18257200111572]

Moist Heat or Steam Sterilization

[18257200111572]

Moist Heat or Steam Sterilization

[18257200111572]

Moist Heat or Steam Sterilization

[18257200111572]

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 NXG]

18257200133093FIREBIRD NXG - INSTRUMENT TRAY-1 KIT (36-9091)
18257200131761REDUCTION SET SCREW INSERTER
18257200131136FIREBIRD NXG - TRAY, REDUCTION IMPLANT / INSTRUMENT CASE
18257200131129FIREBIRD NXG - BASE, REDUCTION IMPLANT / INSTRUMENT CASE
18257200131112FIREBIRD NXG - LID, REDUCTION IMPLANT / INSTRUMENT CASE
18257200131105FIREBIRD NXG - ANTI-SPLAY CAP CADDY
18257200131099FIREBIRD NXG - REDUCTION BODY CADDY
18257200131075FIREBIRD NXG - REDUCTION IMPLANT / INSTRUMENT CASE
18257200130313FIREBIRD NXG - LATERAL OFFSET AND ROD CONNECTOR CADDY KIT (36-9103)
18257200130306FIREBIRD NXG - IMPLANT TRAY KIT (36-9099)
18257200130290MODULAR SCREW DRIVER
18257200123735FIREBIRD NXG - IMPLANT TRAY KIT (36-9099)
18257200122264ROD CONNECTOR, FRONT LOADING
18257200122257AXIAL ROD CONNECTOR
18257200122240LOW PROFILE OFFSET, 35MM
18257200122233LOW PROFILE OFFSET, 32MM
18257200122226LOW PROFILE OFFSET, 29MM
18257200122219LOW PROFILE OFFSET, 26MM
18257200122202LOW PROFILE OFFSET, 23MM
18257200122196LOW PROFILE OFFSET, 20MM
18257200122189LOW PROFILE OFFSET, 17MM
18257200121069REDUCTION BODY
18257200121045SET SCREW INSERTER
18257200121038SET SCREW DRIVER
18257200120253FIREBIRD NXG - 7.5MM MODULAR NON-CANNULATED SCREW CADDY KIT (36-9102)
18257200120246FIREBIRD NXG - 6.5MM MODULAR NON-CANNULATED SCREW CADDY KIT (36-9101)
18257200120239FIREBIRD NXG - 5.5MM MODULAR NON-CANNULATED SCREW CADDY KIT (36-9099)
18257200120222FIREBIRD NXG - 7.5MM MODULAR CANNULATED SCREW CADDY KIT (36-9097)
18257200120215FIREBIRD NXG - 6.5MM MODULAR CANNULATED SCREW CADDY KIT (36-9096)
18257200120208FIREBIRD NXG - 5.5MM MODULAR CANNULATED SCREW CADDY KIT (36-9095)
18257200120192FIREBIRD NXG - 4.5MM MODULAR NON-CANNULATED SCREW CADDY KIT (36-9094)
18257200120130FIREBIRD NXG - 8.5MM BONE SCREW CADDY, IMPLANT CASE
18257200120123FIREBIRD NXG - 7.5MM BONE SCREW CADDY, IMPLANT CASE
18257200120116FIREBIRD NXG - 6.5MM BONE SCREW CADDY, IMPLANT CASE
18257200120109FIREBIRD NXG - 5.5MM BONE SCREW CADDY, IMPLANT CASE
18257200120093FIREBIRD NXG - 4.5MM BONE SCREW CADDY, IMPLANT CASE
18257200120086FIREBIRD NXG - BASE, IMPLANT CASE
18257200120079FIREBIRD NXG - IMPLANT CASE
18257200119851MODULAR SCREW DRIVER
18257200119844MULTI-AXIAL SCREW DRIVER
18257200118465SET SCREW DRIVER
18257200113033FIREBIRD NXG - 7.5MM MODULAR NON-CANNULATED SCREW CADDY KIT (36-9102)
18257200113026FIREBIRD NXG - 6.5MM MODULAR NON-CANNULATED SCREW CADDY KIT (36-9101)
18257200113019FIREBIRD NXG - 5.5MM MODULAR NON-CANNULATED SCREW CADDY KIT (36-9099)
18257200113002FIREBIRD NXG - 8.5MM MODULAR SCREW CADDY KIT (36-9098)
18257200112999FIREBIRD NXG - 7.5MM MODULAR CANNULATED SCREW CADDY KIT (36-9097)
18257200112982FIREBIRD NXG - 6.5MM MODULAR CANNULATED SCREW CADDY KIT (36-9096)
18257200112975FIREBIRD NXG - 5.5MM MODULAR CANNULATED SCREW CADDY KIT (36-9095)
18257200112968FIREBIRD NXG - 4.5MM MODULAR NON-CANNULATED SCREW CADDY KIT (36-9094)
18257200112951FIREBIRD NXG - IMPLANT TRAY KIT (36-9093)
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