PILLAR XL

GUDID 18257200071357

LORDOTIC IMPLANT 12X45X9MM

ORTHOFIX INC.

Metallic spinal interbody fusion cage
Primary Device ID18257200071357
NIH Device Record Key0be1bbb3-35b9-4950-a356-5de5942d14a6
Commercial Distribution StatusIn Commercial Distribution
Brand NamePILLAR XL
Version Model Number73-2209
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
GS118257200071357 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral fusion device with bone graft, lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[18257200071357]

Moist Heat or Steam Sterilization

[18257200071357]

Moist Heat or Steam Sterilization

[18257200071357]

Moist Heat or Steam Sterilization

[18257200071357]

Moist Heat or Steam Sterilization

[18257200071357]

Moist Heat or Steam Sterilization

[18257200071357]

Moist Heat or Steam Sterilization

[18257200071357]

Moist Heat or Steam Sterilization

[18257200071357]

Moist Heat or Steam Sterilization

[18257200071357]

Moist Heat or Steam Sterilization

[18257200071357]

Moist Heat or Steam Sterilization

[18257200071357]

Moist Heat or Steam Sterilization

[18257200071357]

Moist Heat or Steam Sterilization

[18257200071357]

Moist Heat or Steam Sterilization

[18257200071357]

Moist Heat or Steam Sterilization

[18257200071357]

Moist Heat or Steam Sterilization

[18257200071357]

Moist Heat or Steam Sterilization

[18257200071357]

Moist Heat or Steam Sterilization

[18257200071357]

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 XL]

18257200081899PILLAR XL, LATERAL INSTRUMENT TRAY (72-0012)
18257200081882PILLAR XL, LATERAL IMPLANTS, LORDOTIC (72-0011)
18257200081875PILLAR XL, LATERAL IMPLANTS, PARRALEL (72-0010)
18257200072767LORDOTIC IMPLANT 18X55X20MM
18257200072750LORDOTIC IMPLANT 18X55X19MM
18257200072743LORDOTIC IMPLANT 18X55X18MM
18257200072736LORDOTIC IMPLANT 18X55X17MM
18257200072729LORDOTIC IMPLANT 18X55X16MM
18257200072712LORDOTIC IMPLANT 18X55X15MM
18257200072705LORDOTIC IMPLANT 18X55X14MM
18257200072699LORDOTIC IMPLANT 18X55X13MM
18257200072682LORDOTIC IMPLANT 18X55X12MM
18257200072675LORDOTIC IMPLANT 18X55X11MM
18257200072668LORDOTIC IMPLANT 18X55X10MM
18257200072651LORDOTIC IMPLANT 18X55X9MM
18257200072644LORDOTIC IMPLANT 18X55X8MM
18257200072637LORDOTIC IMPLANT 18X50X20MM
18257200072620LORDOTIC IMPLANT 18X50X19MM
18257200072613LORDOTIC IMPLANT 18X50X18MM
18257200072606LORDOTIC IMPLANT 18X50X17MM
18257200072590LORDOTIC IMPLANT 18X50X16MM
18257200072583LORDOTIC IMPLANT 18X50X15MM
18257200072576LORDOTIC IMPLANT 18X50X14MM
18257200072569LORDOTIC IMPLANT 18X50X13MM
18257200072552LORDOTIC IMPLANT 18X50X12MM
18257200072545LORDOTIC IMPLANT 18X50X11MM
18257200072538LORDOTIC IMPLANT 18X50X10MM
18257200072521LORDOTIC IMPLANT 18X50X9MM
18257200072514LORDOTIC IMPLANT 18X50X8MM
18257200072507LORDOTIC IMPLANT 18X45X20MM
18257200072491LORDOTIC IMPLANT 18X45X19MM
18257200072484LORDOTIC IMPLANT 18X45X18MM
18257200072477LORDOTIC IMPLANT 18X45X17MM
18257200072460LORDOTIC IMPLANT 18X45X16MM
18257200072453LORDOTIC IMPLANT 18X45X15MM
18257200072446LORDOTIC IMPLANT 18X45X14MM
18257200072439LORDOTIC IMPLANT 18X45X13MM
18257200072422LORDOTIC IMPLANT 18X45X12MM
18257200072415LORDOTIC IMPLANT 18X45X11MM
18257200072408LORDOTIC IMPLANT 18X45X10MM
18257200072392LORDOTIC IMPLANT 18X45X9MM
18257200072385LORDOTIC IMPLANT 18X45X8MM
18257200072378LORDOTIC IMPLANT 18X40X20MM
18257200072361LORDOTIC IMPLANT 18X40X19MM
18257200072354LORDOTIC IMPLANT 18X40X18MM
18257200072347LORDOTIC IMPLANT 18X40X17MM
18257200072330LORDOTIC IMPLANT 18X40X16MM
18257200072323LORDOTIC IMPLANT 18X40X15MM
18257200072316LORDOTIC IMPLANT 18X40X14MM
18257200072309LORDOTIC IMPLANT 18X40X13MM
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