CONSTRUX - MINI PTC

GUDID 18257200031115

12MM L X 15MM W, 14MM H PARALLEL IMPLANT, STERILE

ORTHOFIX INC.

Metallic spinal interbody fusion cage
Primary Device ID18257200031115
NIH Device Record Key23a054a0-9362-46d4-b00f-c6cacc7ce3c9
Commercial Distribution StatusIn Commercial Distribution
Brand NameCONSTRUX - MINI PTC
Version Model Number37-4114SP
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
GS118257200031115 [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

[18257200031115]

Moist Heat or Steam Sterilization


[18257200031115]

Moist Heat or Steam Sterilization


[18257200031115]

Moist Heat or Steam Sterilization


[18257200031115]

Moist Heat or Steam Sterilization


[18257200031115]

Moist Heat or Steam Sterilization


[18257200031115]

Moist Heat or Steam Sterilization


[18257200031115]

Moist Heat or Steam Sterilization


[18257200031115]

Moist Heat or Steam Sterilization


[18257200031115]

Moist Heat or Steam Sterilization


[18257200031115]

Moist Heat or Steam Sterilization


[18257200031115]

Moist Heat or Steam Sterilization


[18257200031115]

Moist Heat or Steam Sterilization


[18257200031115]

Moist Heat or Steam Sterilization


[18257200031115]

Moist Heat or Steam Sterilization


[18257200031115]

Moist Heat or Steam Sterilization


[18257200031115]

Moist Heat or Steam Sterilization


[18257200031115]

Moist Heat or Steam Sterilization


[18257200031115]

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 PTC]

18257200132690DOUBLE ENDED TRIAL - 15MM W X 15MM D X 12MM/13MM H, 5DEG LORDOTIC
18257200132676DOUBLE ENDED TRIAL - 15MM W X 15MM D X 10MM/11MM H, 5DEG LORDOTIC
18257200132652DOUBLE ENDED TRIAL - 15MM W X 15MM D X 8MM/9MM H, 5DEG LORDOTIC
18257200132638DOUBLE ENDED TRIAL - 15MM W X 15MM D X 6MM/7MM H, 5DEG LORDOTIC
18257200132591DOUBLE ENDED TRIAL -15MM W X 12MM D X 12MM/13MM H, 5DEG LORDOTIC
18257200132577DOUBLE ENDED TRIAL -15MM W X 12MM D X 10MM/11MM H, 5DEG LORDOTIC
18257200132553DOUBLE ENDED TRIAL -15MM W X 12MM D X 8MM/9MM H, 5DEG LORDOTIC
18257200132539DOUBLE ENDED TRIAL -15MM W X 12MM D X 6MM/7MM H, 5DEG LORDOTIC
18257200132492DOUBLE ENDED TRIAL -12MM W X 12MM D X 12MM/13MM H, 5DEG LORDOTIC
18257200132478DOUBLE ENDED TRIAL -12MM W X 12MM D X 10MM/11MM H, 5DEG LORDOTIC
18257200132454DOUBLE ENDED TRIAL -12MM W X 12MM D X 8MM/9MM H, 5DEG LORDOTIC
18257200132430DOUBLE ENDED TRIAL -12MM W X 12MM D X 6MM/7MM H, 5DEG LORDOTIC
18257200132416RASP - 15MM W X 12MM D X 14MM H, 5DEG LORDOTIC
18257200132409RASP - 15MM W X 12MM D X 13MM H, 5DEG LORDOTIC
18257200132393RASP - 15MM W X 12MM D X 12MM H, 5DEG LORDOTIC
18257200132386RASP - 15MM W X 12MM D X 11MM H, 5DEG LORDOTIC
18257200132379RASP - 15MM W X 12MM D X 10MM H, 5DEG LORDOTIC
18257200132362RASP - 15MM W X 12MM D X 9MM H, 5DEG LORDOTIC
18257200132355RASP - 15MM W X 12MM D X 8MM H, 5DEG LORDOTIC
18257200132348RASP - 15MM W X 12MM D X 7MM H, 5DEG LORDOTIC
18257200132331RASP - 15MM W X 12MM D X 6MM H, 5DEG LORDOTIC
18257200132317RASP - 12MM W X 12MM D X 14MM H, 5DEG LORDOTIC
18257200132300RASP - 12MM W X 12MM D X 13MM H, 5DEG LORDOTIC
18257200132294RASP - 12MM W X 12MM D X 12MM H, 5DEG LORDOTIC
18257200132287RASP - 12MM W X 12MM D X 11MM H, 5DEG LORDOTIC
18257200132270RASP - 12MM W X 12MM D X 10MM H, 5DEG LORDOTIC
18257200132263RASP - 12MM W X 12MM D X 9MM H, 5DEG LORDOTIC
18257200132256RASP - 12MM W X 12MM D X 8MM H, 5DEG LORDOTIC
18257200132249RASP - 12MM W X 12MM D X 7MM H, 5DEG LORDOTIC
18257200132232RASP - 12MM W X 12MM D X 6MM H, 5DEG LORDOTIC
18257200093816COMPLETE IMPLANT SET - CONSTRUX MINI PTC SPACER SYSTEM
1825720008245215MM X 15MM - TRIAL SIZERS WITH CADDY - COMPLETE ASSEMBLY, CONSTRUX MINI PEEK SPACER SYSTEM (37-
18257200031672CADDY ASSEMBLY, 15MM X 15MM - TRIAL SIZERS - CONSTRUX MINI PEEK SPACER SYSTEM
1825720003165815MM L X 15MM W, 14 MM H, PARALLEL TRIAL
1825720003164115MM L X 15MM W, 13 MM H, PARALLEL TRIAL
1825720003163415MM L X 15MM W, 12 MM H, PARALLEL TRIAL
1825720003162715MM L X 15MM W, 11 MM H, PARALLEL TRIAL
1825720003161015MM L X 15MM W, 10 MM H, PARALLEL TRIAL
1825720003160315MM L X 15MM W, 9 MM H, PARALLEL TRIAL
1825720003159715MM L X 15MM W, 8 MM H, PARALLEL TRIAL
1825720003158015MM L X 15MM W, 7 MM H, PARALLEL TRIAL
1825720003157315MM L X 15MM W, 6 MM H, PARALLEL TRIAL
1825720003156615MM L X 15MM W, 14 MM H, LORDOTIC TRIAL
1825720003155915MM L X 15MM W, 13 MM H, LORDOTIC TRIAL
1825720003154215MM L X 15MM W, 12 MM H, LORDOTIC TRIAL
1825720003153515MM L X 15MM W, 11 MM H, LORDOTIC TRIAL
1825720003152815MM L X 15MM W, 10 MM H, LORDOTIC TRIAL
1825720003151115MM L X 15MM W, 9 MM H, LORDOTIC TRIAL
1825720003150415MM L X 15MM W, 8 MM H, LORDOTIC TRIAL
1825720003149815MM L X 15MM W, 7 MM H, LORDOTIC TRIAL

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