NAVIGATED INSTRUMENTS;FIREBIRD NXG

GUDID 18257200119325

BONE TAP, 5.5MM, JANUS NAVIGATED MDT

ORTHOFIX INC.

Growth-correction orthopaedic fixation plate kit
Primary Device ID18257200119325
NIH Device Record Key0d2fa312-eae6-42ae-a12c-a44c817c7d6f
Commercial Distribution StatusIn Commercial Distribution
Brand NameNAVIGATED INSTRUMENTS;FIREBIRD NXG
Version Model Number36-1345
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
GS118257200119325 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OLOOrthopedic stereotaxic instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[18257200119325]

Moist Heat or Steam Sterilization


[18257200119325]

Moist Heat or Steam Sterilization


[18257200119325]

Moist Heat or Steam Sterilization


[18257200119325]

Moist Heat or Steam Sterilization


[18257200119325]

Moist Heat or Steam Sterilization


[18257200119325]

Moist Heat or Steam Sterilization


[18257200119325]

Moist Heat or Steam Sterilization


[18257200119325]

Moist Heat or Steam Sterilization


[18257200119325]

Moist Heat or Steam Sterilization


[18257200119325]

Moist Heat or Steam Sterilization


[18257200119325]

Moist Heat or Steam Sterilization


[18257200119325]

Moist Heat or Steam Sterilization


[18257200119325]

Moist Heat or Steam Sterilization


[18257200119325]

Moist Heat or Steam Sterilization


[18257200119325]

Moist Heat or Steam Sterilization


[18257200119325]

Moist Heat or Steam Sterilization


[18257200119325]

Moist Heat or Steam Sterilization


[18257200119325]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-03-27
Device Publish Date2019-03-19

On-Brand Devices [NAVIGATED INSTRUMENTS;FIREBIRD NXG]

18257200121816AWL, NAVIGATED BL
18257200121809AWL, NAVIGATED MDT
18257200119820REDUCTION SCREW DRIVER, FIREBIRD NAVIGATED BL
18257200119813REDUCTION SCREW DRIVER, FIREBIRD NAVIGATED MDT
18257200119653MONOAXIAL SCREW DRIVER, FIREBIRD NAVIGATED, BL
18257200119646MULTIAXIAL SCREW DRIVER, FIREBIRD NAVIGATED, BL
18257200119639MODULAR SCREW DRIVER, FIREBIRD NAVIGATED BL
18257200119622CANNULATED BONE TAP, 7.5MM, JANUS NAVIGATED BL
18257200119615CANNULATED BONE TAP, 6.5MM, JANUS NAVIGATED BL
18257200119608CANNULATED BONE TAP, 5.5MM, JANUS NAVIGATED BL
18257200119592CANNULATED BONE TAP, 4.5MM, JANUS NAVIGATED, BL
18257200119585BONE TAP, 7.5MM, JANUS NAVIGATED BL
18257200119578BONE TAP, 6.5MM, JANUS NAVIGATED BL
18257200119561BONE TAP, 5.5MM, JANUS NAVIGATED BL
18257200119554BONE TAP, 4.5MM, JANUS NAVIGATED BL
18257200119547BONE TAP, 8.5MM, FIREBIRD NAVIGATED BL
18257200119530BONE TAP, 7.5MM, FIREBIRD NAVIGATED BL
18257200119523BONE TAP, 6.5MM, FIREBIRD NAVIGATED BL
18257200119516BONE TAP, 5.5MM, FIREBIRD NAVIGATED BL
18257200119509BONE TAP, 4.5MM, FIREBIRD NAVIGATED BL
18257200119493CANNULATED AWL, NAVIGATED BL
18257200119486BONE PROBE, STRAIGHT THORACIC, NAVIGATED BL
18257200119417MONOAXIAL SCREW DRIVER, FIREBIRD NAVIGATED MDT
18257200119400MULTIAXIAL SCREW DRIVER, FIREBIRD NAVIGATED MDT
18257200119394MODULAR SCREW DRIVER, FIREBIRD NAVIGATED MDT
18257200119387CANNULATED BONE TAP, 7.5MM, JANUS NAVIGATED, MDT
18257200119370CANNULATED BONE TAP, 6.5MM, JANUS NAVIGATED, MDT
18257200119363CANNULATED BONE TAP, 5.5MM, JANUS NAVIGATED, MDT
18257200119356CANNULATED BONE TAP, 4.5MM, JANUS NAVIGATED, MDT
18257200119349BONE TAP, 7.5MM, JANUS NAVIGATED MDT
18257200119332BONE TAP, 6.5MM, JANUS NAVIGATED MDT
18257200119325BONE TAP, 5.5MM, JANUS NAVIGATED MDT
18257200119318BONE TAP, 4.5MM, JANUS NAVIGATED MDT
18257200119301BONE TAP, 8.5MM, FIREBIRD NAVIGATED MDT
18257200119295BONE TAP, 7.5MM, FIREBIRD NAVIGATED MDT
18257200119288BONE TAP, 6.5MM, FIREBIRD NAVIGATED MDT
18257200119271BONE TAP, 5.5MM, FIREBIRD NAVIGATED MDT
18257200119264BONE TAP, 4.5MM, FIREBIRD NAVIGATED MDT
18257200119257CANNULATED AWL, NAVIGATED MDT
18257200119240BONE PROBE, STRAIGHT THORACIC, NAVIGATED MDT
18257200131365BONE PROBE, STRAIGHT DUCKBILL, NAVIGATED BL
18257200131358BONE PROBE, STRAIGHT DUCKBILL, NAVIGATED MDT

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