PILLAR SA 49-0011

GUDID 18257200081738

PILLAR SA IMPLANTS AND TRIALS (49-0011)

ORTHOFIX INC.

Metallic spinal interbody fusion cage
Primary Device ID18257200081738
NIH Device Record Key01c825b6-acfe-4ca4-a24c-4b559ead0427
Commercial Distribution StatusIn Commercial Distribution
Brand NamePILLAR SA
Version Model Number450262-0001
Catalog Number49-0011
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
GS118257200081738 [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

[18257200081738]

Moist Heat or Steam Sterilization


[18257200081738]

Moist Heat or Steam Sterilization


[18257200081738]

Moist Heat or Steam Sterilization


[18257200081738]

Moist Heat or Steam Sterilization


[18257200081738]

Moist Heat or Steam Sterilization


[18257200081738]

Moist Heat or Steam Sterilization


[18257200081738]

Moist Heat or Steam Sterilization


[18257200081738]

Moist Heat or Steam Sterilization


[18257200081738]

Moist Heat or Steam Sterilization


[18257200081738]

Moist Heat or Steam Sterilization


[18257200081738]

Moist Heat or Steam Sterilization


[18257200081738]

Moist Heat or Steam Sterilization


[18257200081738]

Moist Heat or Steam Sterilization


[18257200081738]

Moist Heat or Steam Sterilization


[18257200081738]

Moist Heat or Steam Sterilization


[18257200081738]

Moist Heat or Steam Sterilization


[18257200081738]

Moist Heat or Steam Sterilization


[18257200081738]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-02-24
Device Publish Date2019-03-12

On-Brand Devices [PILLAR SA]

18257200118168PILLAR SA INST (49-0021)
18257200081943CADDY, 43W X 32D X 12DEG (49-4422)
18257200081936CADDY, 43W X 28D X 12DEG (49-4412)
18257200081929CADDY, 43W X 32D X 7DEG (49-4317)
18257200081912CADDY, 43W X 28D X 7DEG (49-4307)
18257200081851CADDY, 40W X 32D X 12DEG (49-4132)
18257200081844CADDY, 40W X 32D X 7DEG (49-4017)
18257200081837CADDY, 37W X 32D X 12DEG (49-3722)
18257200081820CADDY, 37W X 32D X 7DEG (49-3717)
18257200081813CADDY, 33W X 32D X 12DEG (49-3332)
18257200081806CADDY, 33W X 32D X 7DEG (49-3317)
18257200081790CADDY, 40W X 28D X 12DEG (49-4122)
18257200081783CADDY, 40W X 28D X 7DEG (49-4007)
18257200081776CADDY, 37W X 28D X 12DEG (49-3712)
18257200081769CADDY, 37W X 28D X 7DEG (49-3707)
18257200081752CADDY, 33W X 28D X 12DEG (49-3322)
18257200081745CADDY, 33W X 28D X 7DEG (49-3307)
18257200081738PILLAR SA IMPLANTS AND TRIALS (49-0011)
18257200045143PILLAR SA TRIAL 33X32X20, 12DEG LORDOTIC
18257200045136PILLAR SA TRIAL 33X32X18, 12DEG LORDOTIC
18257200045129PILLAR SA TRIAL 33X32X16, 12DEG LORDOTIC
18257200045112PILLAR SA TRIAL 33X32X14, 12DEG LORDOTIC
18257200045105PILLAR SA TRIAL 33X32X12.5, 12DEG LORDOTIC
18257200045099PILLAR SA TRIAL 33X32X20, 7DEG LORDOTIC
18257200045082PILLAR SA TRIAL 33X32X18, 7DEG LORDOTIC
18257200045075PILLAR SA TRIAL 33X32X16, 7DEG LORDOTIC
18257200045068PILLAR SA TRIAL 33X32X14, 7DEG LORDOTIC
18257200045051PILLAR SA TRIAL 33X32X12.5, 7DEG LORDOTIC
18257200045044PILLAR SA TRIAL 33X28X20, 12DEG LORDOTIC
18257200045037PILLAR SA TRIAL 33X28X18, 12DEG LORDOTIC
18257200045020PILLAR SA TRIAL 33X28X16, 12DEG LORDOTIC
18257200045013PILLAR SA TRIAL 33X28X14, 12DEG LORDOTIC
18257200045006PILLAR SA TRIAL 33X28X12.5, 12DEG LORDOTIC
18257200044993PILLAR SA TRIAL 33X28X20, 7DEG LORDOTIC
18257200044986PILLAR SA TRIAL 33X28X18, 7DEG LORDOTIC
18257200044979PILLAR SA TRIAL 33X28X16, 7DEG LORDOTIC
18257200044962PILLAR SA TRIAL 33X28X14, 7DEG LORDOTIC
18257200044955PILLAR SA TRIAL 33X28X12.5, 7DEG LORDOTIC
18257200044948PILLAR SA TRIAL 43X32X20, 12DEG LORDOTIC
18257200044931PILLAR SA TRIAL 43X32X18, 12DEG LORDOTIC
18257200044924PILLAR SA TRIAL 43X32X16, 12DEG LORDOTIC
18257200044917PILLAR SA TRIAL 43X32X14, 12DEG LORDOTIC
18257200044900PILLAR SA TRIAL 43X32X12.5, 12DEG LORDOTIC
18257200044894PILLAR SA TRIAL 43X32X20, 7DEG LORDOTIC
18257200044887PILLAR SA TRIAL 43X32X18, 7DEG LORDOTIC
18257200044870PILLAR SA TRIAL 43X32X16, 7DEG LORDOTIC
18257200044863PILLAR SA TRIAL 43X32X14, 7DEG LORDOTIC
18257200044856PILLAR SA TRIAL 43X32X12.5, 7DEG LORDOTIC
18257200044849PILLAR SA TRIAL 40X32X20, 12DEG LORDOTIC
18257200044832PILLAR SA TRIAL 40X32X18, 12DEG LORDOTIC

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