FIREBIRD SFS

GUDID 18257200115044

7.5MM X 55MM HA COATED BONE SCREW SELF-TAPPING, CANNULATED, STERILE

ORTHOFIX INC.

Bone-screw internal spinal fixation system, sterile
Primary Device ID18257200115044
NIH Device Record Key03592553-9057-48b5-968b-f4196f5f4dcd
Commercial Distribution StatusIn Commercial Distribution
Brand NameFIREBIRD SFS
Version Model Number77-5755SP
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
GS118257200115044 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKBThoracolumbosacral pedicle screw system

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[18257200115044]

Moist Heat or Steam Sterilization

[18257200115044]

Moist Heat or Steam Sterilization

[18257200115044]

Moist Heat or Steam Sterilization

[18257200115044]

Moist Heat or Steam Sterilization

[18257200115044]

Moist Heat or Steam Sterilization

[18257200115044]

Moist Heat or Steam Sterilization

[18257200115044]

Moist Heat or Steam Sterilization

[18257200115044]

Moist Heat or Steam Sterilization

[18257200115044]

Moist Heat or Steam Sterilization

[18257200115044]

Moist Heat or Steam Sterilization

[18257200115044]

Moist Heat or Steam Sterilization

[18257200115044]

Moist Heat or Steam Sterilization

[18257200115044]

Moist Heat or Steam Sterilization

[18257200115044]

Moist Heat or Steam Sterilization

[18257200115044]

Moist Heat or Steam Sterilization

[18257200115044]

Moist Heat or Steam Sterilization

[18257200115044]

Moist Heat or Steam Sterilization

[18257200115044]

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 [FIREBIRD SFS]

18257200130153FIREBIRD 2.0 - 8.5MM ASSEMBLED CADDY
18257200130146FIREBIRD 2.0 - 8.5MM MODULAR CADDY
18257200130139FIREBIRD 2.0 - 7.5MM ASSEMBLED CADDY
18257200130122FIREBIRD 2.0 - 7.5MM MODULAR CADDY
18257200130115FIREBIRD 2.0 - 6.5MM ASSEMBLED CADDY - DOUBLE WIDE
18257200130108FIREBIRD 2.0 - 6.5MM ASSEMBLED CADDY
18257200130092FIREBIRD 2.0 - 6.5MM MODULAR CADDY - DOUBLE WIDE
18257200130085FIREBIRD 2.0 - 6.5MM MODULAR CADDY
18257200130078FIREBIRD 2.0 - 5.5MM ASSEMBLED CADDY - DOUBLE WIDE
18257200130061FIREBIRD 2.0 - 5.5MM ASSEMBLED CADDY
18257200130054FIREBIRD 2.0 - 5.5MM MODULAR CADDY - DOUBLE WIDE
18257200130047FIREBIRD 2.0 - 5.5MM MODULAR CADDY
18257200130030FIREBIRD 2.0 - 4.5MM ASSEMBLED CADDY
18257200130023FIREBIRD 2.0 - 4.5MM MODULAR CADDY
18257200130016FIREBIRD 2.0 - 4.0MM ASSEMBLED CADDY
18257200130009FIREBIRD 2.0 - 4.0MM MODULAR CADDY
182572001285877.5MM X 95MM MULTI-AXIAL SCREW, SELF-TAPPING, CANNULATED
182572001285707.5MM X 90MM MULTI-AXIAL SCREW, SELF-TAPPING, CANNULATED
182572001285637.5MM X 85MM MULTI-AXIAL SCREW, SELF-TAPPING, CANNULATED
182572001285567.5MM X 80MM MULTI-AXIAL SCREW, SELF-TAPPING, CANNULATED
182572001285497.5MM X 75MM MULTI-AXIAL SCREW, SELF-TAPPING, CANNULATED
182572001285327.5MM X 70MM MULTI-AXIAL SCREW, SELF-TAPPING, CANNULATED
182572001285257.5MM X 65MM MULTI-AXIAL SCREW, SELF-TAPPING, CANNULATED
182572001285187.5MM X 60MM MULTI-AXIAL SCREW, SELF-TAPPING, CANNULATED
182572001285017.5MM X 55MM MULTI-AXIAL SCREW, SELF-TAPPING, CANNULATED
182572001284957.5MM X 50MM MULTI-AXIAL SCREW, SELF-TAPPING, CANNULATED
182572001284887.5MM X 45MM MULTI-AXIAL SCREW, SELF-TAPPING, CANNULATED
182572001284717.5MM X 40MM MULTI-AXIAL SCREW, SELF-TAPPING, CANNULATED
182572001284647.5MM X 35MM MULTI-AXIAL SCREW, SELF-TAPPING, CANNULATED
182572001284577.5MM X 30MM MULTI-AXIAL SCREW, SELF-TAPPING, CANNULATED
182572001284407.5MM X 25MM MULTI-AXIAL SCREW, SELF-TAPPING, CANNULATED
182572001284337.5MM X 110MM MULTI-AXIAL SCREW, SELF-TAPPING, CANNULATED
182572001284267.5MM X 100MM MULTI-AXIAL SCREW, SELF-TAPPING, CANNULATED
182572001284196.5MM X 95MM MULTI-AXIAL SCREW, SELF-TAPPING, CANNULATED
182572001284026.5MM X 90MM MULTI-AXIAL SCREW, SELF-TAPPING, CANNULATED
182572001283966.5MM X 85MM MULTI-AXIAL SCREW, SELF-TAPPING, CANNULATED
182572001283896.5MM X 80MM MULTI-AXIAL SCREW, SELF-TAPPING, CANNULATED
182572001283726.5MM X 75MM MULTI-AXIAL SCREW, SELF-TAPPING, CANNULATED
182572001283656.5MM X 70MM MULTI-AXIAL SCREW, SELF-TAPPING, CANNULATED
182572001283586.5MM X 65MM MULTI-AXIAL SCREW, SELF-TAPPING, CANNULATED
182572001283416.5MM X 60MM MULTI-AXIAL SCREW, SELF-TAPPING, CANNULATED
182572001283346.5MM X 55MM MULTI-AXIAL SCREW, SELF-TAPPING, CANNULATED
182572001283276.5MM X 50MM MULTI-AXIAL SCREW, SELF-TAPPING, CANNULATED
182572001283106.5MM X 45MM MULTI-AXIAL SCREW, SELF-TAPPING, CANNULATED
182572001283036.5MM X 40MM MULTI-AXIAL SCREW, SELF-TAPPING, CANNULATED
182572001282976.5MM X 35MM MULTI-AXIAL SCREW, SELF-TAPPING, CANNULATED
182572001282806.5MM X 30MM MULTI-AXIAL SCREW, SELF-TAPPING, CANNULATED
182572001282736.5MM X 25MM MULTI-AXIAL SCREW, SELF-TAPPING, CANNULATED
182572001282666.5MM X 110MM MULTI-AXIAL SCREW, SELF-TAPPING, CANNULATED
182572001282596.5MM X 100MM MULTI-AXIAL SCREW, SELF-TAPPING, CANNULATED
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