CONSTRUX - MINI PEEK VBR

GUDID 18257200042203

CONSTRUX MINI 13MM H X 15MM W X 12MM L - 5DEG LORDOTIC

ORTHOFIX INC.

Metallic spinal interbody fusion cage
Primary Device ID18257200042203
NIH Device Record Keyb2d39096-ff22-4884-838b-dbb51d6a8ec1
Commercial Distribution StatusIn Commercial Distribution
Brand NameCONSTRUX - MINI PEEK VBR
Version Model Number47-4013
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 Usefalse
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
GS118257200042203 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ODPIntervertebral fusion device with bone graft, cervical

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[18257200042203]

Moist Heat or Steam Sterilization


[18257200042203]

Moist Heat or Steam Sterilization


[18257200042203]

Moist Heat or Steam Sterilization


[18257200042203]

Moist Heat or Steam Sterilization


[18257200042203]

Moist Heat or Steam Sterilization


[18257200042203]

Moist Heat or Steam Sterilization


[18257200042203]

Moist Heat or Steam Sterilization


[18257200042203]

Moist Heat or Steam Sterilization


[18257200042203]

Moist Heat or Steam Sterilization


[18257200042203]

Moist Heat or Steam Sterilization


[18257200042203]

Moist Heat or Steam Sterilization


[18257200042203]

Moist Heat or Steam Sterilization


[18257200042203]

Moist Heat or Steam Sterilization


[18257200042203]

Moist Heat or Steam Sterilization


[18257200042203]

Moist Heat or Steam Sterilization


[18257200042203]

Moist Heat or Steam Sterilization


[18257200042203]

Moist Heat or Steam Sterilization


[18257200042203]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-02-24
Device Publish Date2019-03-19

On-Brand Devices [CONSTRUX - MINI PEEK VBR]

18257200135813IMPLANT INSERTER ASSEMBLY
18257200082957CONSTRUX MINI PEEK SPACER SYSTEM - INSTRUMENT KIT (47-0012)
18257200081370CONSTRUX MINI, SPACER AND VBR SYSTEMS (47-0010)
18257200042357CONSTRUX MINI 15MM W X 12MM D X 14MM H, PARALLEL
18257200042340CONSTRUX MINI 14MM H X 15MM W X 12MM L - PARALLEL
18257200042333CONSTRUX MINI 15MM W X 12MM D X 13MM H, PARALLEL
18257200042326CONSTRUX MINI 13MM H X 15MM W X 12MM L - PARALLEL
18257200042319CONSTRUX MINI 12MM H X 15MM W X 12MM L - PARALLEL
18257200042302CONSTRUX MINI 11MM H X 15MM W X 12MM L - PARALLEL
18257200042296CONSTRUX MINI 10MM H X 15MM W X 12MM L - PARALLEL
18257200042289CONSTRUX MINI 9MM H X 15MM W X 12MM L - PARALLEL
18257200042272CONSTRUX MINI 8MM H X 15MM W X 12MM L - PARALLEL
18257200042265CONSTRUX MINI 7MM H X 15MM W X 12MM L - PARALLEL
18257200042258CONSTRUX MINI 6MM H X 15MM W X 12MM L - PARALLEL
18257200042241CONSTRUX MINI 5MM H X 15MM W X 12MM L - PARALLEL
18257200042234CONSTRUX MINI 15MM W X 12MM D X 14MM H, 5? LORDOTIC
18257200042227CONSTRUX MINI 14MM H X 15MM W X 12MM L - 5DEG LORDOTIC
18257200042210CONSTRUX MINI 15MM W X 12MM D X 13MM H, 5? LORDOTIC
18257200042203CONSTRUX MINI 13MM H X 15MM W X 12MM L - 5DEG LORDOTIC
18257200042197CONSTRUX MINI 12MM H X 15MM W X 12MM L - 5DEG LORDOTIC
18257200042180CONSTRUX MINI 11MM H X 15MM W X 12MM L - 5DEG LORDOTIC
18257200042173CONSTRUX MINI 10MM H X 15MM W X 12MM L - 5DEG LORDOTIC
18257200042166CONSTRUX MINI 9MM H X 15MM W X 12MM L - 5DEG LORDOTIC
18257200042159CONSTRUX MINI 8MM H X 15MM W X 12MM L - 5DEG LORDOTIC
18257200042142CONSTRUX MINI 7MM H X 15MM W X 12MM L - 5DEG LORDOTIC
18257200042135CONSTRUX MINI 6MM H X 15MM W X 12MM L - 5DEG LORDOTIC
18257200042128CONSTRUX MINI 5MM H X 15MM W X 12MM L - 5DEG LORDOTIC
18257200042111CONSTRUX MINI 12MM W X 12MM D X 14MM H, PARALLEL
18257200042104CONSTRUX MINI 14MM H X 12MM W X 12MM L - PARALLEL
18257200042098CONSTRUX MINI 12MM W X 12MM D X 13MM H, PARALLEL
18257200042081CONSTRUX MINI 13MM H X 12MM W X 12MM L - PARALLEL
18257200042074CONSTRUX MINI 12MM H X 12MM W X 12MM L - PARALLEL
18257200042067CONSTRUX MINI 11MM H X 12MM W X 12MM L - PARALLEL
18257200042050CONSTRUX MINI 10MM H X 12MM W X 12MM L - PARALLEL
18257200042043CONSTRUX MINI 9MM H X 12MM W X 12MM L - PARALLEL
18257200042036CONSTRUX MINI 8MM H X 12MM W X 12MM L - PARALLEL
18257200042029CONSTRUX MINI 7MM H X 12MM W X 12MM L - PARALLEL
18257200042012CONSTRUX MINI 6MM H X 12MM W X 12MM L - PARALLEL
18257200042005CONSTRUX MINI 5MM H X 12MM W X 12MM L - PARALLEL
18257200041992CONSTRUX MINI 12MM W X 12MM D X 14MM H, 5? LORDOTIC
18257200041985CONSTRUX MINI 14MM H X 12MM W X 12MM L - 5DEG LORDOTIC
18257200041978CONSTRUX MINI 12MM W X 12MM D X 13MM H, 5? LORDOTIC
18257200041961CONSTRUX MINI 13MM H X 12MM W X 12MM L - 5DEG LORDOTIC
18257200041954CONSTRUX MINI 12MM H X 12MM W X 12MM L - 5DEG LORDOTIC
18257200041947CONSTRUX MINI 11MM H X 12MM W X 12MM L - 5DEG LORDOTIC
18257200041930CONSTRUX MINI 10MM H X 12MM W X 12MM L - 5DEG LORDOTIC
18257200041923CONSTRUX MINI 9MM H X 12MM W X 12MM L - 5DEG LORDOTIC
18257200041916CONSTRUX MINI 8MM H X 12MM W X 12MM L - 5DEG LORDOTIC
18257200041909CONSTRUX MINI 7MM H X 12MM W X 12MM L - 5DEG LORDOTIC
18257200041893CONSTRUX MINI 6MM H X 12MM W X 12MM L - 5DEG LORDOTIC

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