FIREBIRD SFS;SFS;SFS LE

GUDID 18257200016495

25MM FIXED CROSS CONNECTOR

ORTHOFIX INC.

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID18257200016495
NIH Device Record Keycf09d59d-10b8-4530-8893-f7de519aaa01
Commercial Distribution StatusIn Commercial Distribution
Brand NameFIREBIRD SFS;SFS;SFS LE
Version Model Number57-5325
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
GS118257200016495 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKBThoracolumbosacral pedicle screw system

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[18257200016495]

Moist Heat or Steam Sterilization


[18257200016495]

Moist Heat or Steam Sterilization


[18257200016495]

Moist Heat or Steam Sterilization


[18257200016495]

Moist Heat or Steam Sterilization


[18257200016495]

Moist Heat or Steam Sterilization


[18257200016495]

Moist Heat or Steam Sterilization


[18257200016495]

Moist Heat or Steam Sterilization


[18257200016495]

Moist Heat or Steam Sterilization


[18257200016495]

Moist Heat or Steam Sterilization


[18257200016495]

Moist Heat or Steam Sterilization


[18257200016495]

Moist Heat or Steam Sterilization


[18257200016495]

Moist Heat or Steam Sterilization


[18257200016495]

Moist Heat or Steam Sterilization


[18257200016495]

Moist Heat or Steam Sterilization


[18257200016495]

Moist Heat or Steam Sterilization


[18257200016495]

Moist Heat or Steam Sterilization


[18257200016495]

Moist Heat or Steam Sterilization


[18257200016495]

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

Devices Manufactured by ORTHOFIX INC.

18257200068166 - PILLAR XL2020-02-24 PARALLEL RASP TRIAL - 18XXXX9MM
18257200081387 - CONSTRUX - PEEK VBR2020-02-24 PILLAR AL (48-0010)
18257200131969 - PEMF - PHYSIO-STIM2020-02-24 5302, SHIP ASSY., BONE GROWTH STIMULATOR, PHYSIOSTIM, US
18257200131976 - PEMF - PHYSIO-STIM2020-02-24 5303, SHIP ASSY., BONE GROWTH STIMULATOR, PHYSIOSTIM, US
18257200131983 - PEMF - PHYSIO-STIM2020-02-24 5313, SHIP ASSY., BONE GROWTH STIMULATOR, PHYSIOSTIM, US
18257200131990 - PEMF - PHYSIO-STIM2020-02-24 5314L, SHIP ASSY., BONE GROWTH STIMULATOR, PHYSIOSTIM, US
18257200132003 - PEMF - PHYSIO-STIM2020-02-24 5314R, SHIP ASSY., BONE GROWTH STIMULATOR, PHYSIOSTIM, US
18257200132010 - PEMF - PHYSIO-STIM2020-02-24 5315, SHIP ASSY., BONE GROWTH STIMULATOR, PHYSIOSTIM, US

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