PILLAR TL

GUDID 18257200039777

PILLAR TL SPACER 9X27X15 PARALLEL

ORTHOFIX INC.

Metallic spinal interbody fusion cage
Primary Device ID18257200039777
NIH Device Record Key9d95dbef-3211-4c75-8d6a-950799360080
Commercial Distribution StatusIn Commercial Distribution
Brand NamePILLAR TL
Version Model Number45-7215
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
GS118257200039777 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQPSpinal vertebral body replacement device

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[18257200039777]

Moist Heat or Steam Sterilization


[18257200039777]

Moist Heat or Steam Sterilization


[18257200039777]

Moist Heat or Steam Sterilization


[18257200039777]

Moist Heat or Steam Sterilization


[18257200039777]

Moist Heat or Steam Sterilization


[18257200039777]

Moist Heat or Steam Sterilization


[18257200039777]

Moist Heat or Steam Sterilization


[18257200039777]

Moist Heat or Steam Sterilization


[18257200039777]

Moist Heat or Steam Sterilization


[18257200039777]

Moist Heat or Steam Sterilization


[18257200039777]

Moist Heat or Steam Sterilization


[18257200039777]

Moist Heat or Steam Sterilization


[18257200039777]

Moist Heat or Steam Sterilization


[18257200039777]

Moist Heat or Steam Sterilization


[18257200039777]

Moist Heat or Steam Sterilization


[18257200039777]

Moist Heat or Steam Sterilization


[18257200039777]

Moist Heat or Steam Sterilization


[18257200039777]

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 [PILLAR TL]

18257200081318PILLAR TL PEEK PARTIAL VBR SYSTEM, IMPLANT/INSTRUMENT CASE (45-0051)
18257200081295PILLAR PL/TL VBR SYSTEM, 11MM X 33MM IMPLANTS AND TRIALS (46-0020)
18257200081271PILLAR TL (45-9098)
18257200044160PILLAR SA 12DEG X 20H DISTRACTOR / SIZER
18257200043842PILLAR SA 7DEG X 20H DISTRACTOR / SIZER
18257200043781PILLAR SA IMPLANT-TRIAL CASE W-CADDIES-EMPTY
18257200041428PILLAR TL TRIAL 11X33X16 PARALLEL
18257200041411PILLAR TL TRIAL 11X33X15 PARALLEL
18257200041404PILLAR TL TRIAL 11X33X14 PARALLEL
18257200041398PILLAR TL TRIAL 11X33X13 PARALLEL
18257200041381PILLAR TL TRIAL 11X33X12 PARALLEL
18257200041374PILLAR TL TRIAL 11X33X11 PARALLEL
18257200041367PILLAR TL TRIAL 11X33X10 PARALLEL
18257200041350PILLAR TL TRIAL 11X33X9 PARALLEL
18257200041343PILLAR TL TRIAL 11X33X8 PARALLEL
18257200041336PILLAR TL TRIAL 11X33X7 PARALLEL
18257200041329PILLAR TL TRIAL 11X33X6 PARALLEL
18257200040919PILLAR PL-TL 11MM NARROW TAMP
18257200040902PILLAR PL-TL 9MM 30DEG NARROW TAMP
18257200040896.75 WIDE RASP
18257200040889.32 NARROW RASP
18257200040872CURRETTE 6" MODULAR HANDLE INSERT
18257200040865CURRETTE 6" MODULAR HANDLE
18257200040858MODULAR HANDLE INSERT, 10"
18257200040841CURETTE MODULAR HANDLE, 10"
18257200040834PILLAR TL TRIAL 9X27X7, 8DEG LORDOTIC
18257200040827PILLAR TL TRIAL 9X27X6, 8DEG LORDOTIC
18257200040810PILLAR TL TRIAL 9X27X7 PARALLEL
18257200040803PILLAR TL TRIAL 9X27X6 PARALLEL
18257200040797PILLARL PL TRIAL 9X23X7, 8DEG LORDOTIC
18257200040780PILLAR PL TRIAL 9X23X6, 8DEG LORDOTIC
18257200040773PILLAR PL TRIAL 9X23X7 PARALLEL
18257200040766PILLAR PL TRIAL 9X23X6 PARALLEL
18257200040759NO. 1 OVAL GOUGE, 6"
1825720004074245DEG DOUBLE SIDED RASP 6X16
182572000407356MM X 16MM STRAIGHT DOUBLE SIDED RASP
18257200040728NO. 1 30DEG RIGHT CURETTE ,6"
18257200040711NO. 1 30DEG LEFT CURETTE, 6"
18257200040704NO. 1 STRAIGHT CURETTE, 6"
18257200040698NO. 0 30DEG RIGHT CURETTE, 6"
18257200040681NO. 0 30DEG LEFT CURETTE, 6"
18257200040674NO. 0 STRAIGHT CURETTE, 6"
18257200040667PILLAR TL TRIAL 9X27X16, 8DEG LORDOTIC
18257200040650PILLAR TL TRIAL 9X27X15, 8DEG LORDOTIC
18257200040643PILLAR TL TRIAL 9X27X14, 8DEG LORDOTIC
18257200040636PILLAR TL TRIAL 9X27X13, 8DEG LORDOTIC
18257200040629PILLAR TL TRIAL 9X27X12, 8DEG LORDOTIC
18257200040612PILLAR TL TRIAL 9X27X11, 8DEG LORDOTIC
18257200040605PILLAR TL TRIAL 9X27X10, 8DEG LORDOTIC
18257200040599PILLAR TL TRIAL 9X27X9, 8DEG LORDOTIC

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