PILLAR AL

GUDID 18257200043712

PILLAR AL SPACER 34X28X18, 12DEG LORDOTIC

ORTHOFIX INC.

Metallic spinal interbody fusion cage
Primary Device ID18257200043712
NIH Device Record Keycea92590-1e59-4eff-b315-2bb81c58ece3
Commercial Distribution StatusIn Commercial Distribution
Brand NamePILLAR AL
Version Model Number48-4218
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
GS118257200043712 [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

[18257200043712]

Moist Heat or Steam Sterilization


[18257200043712]

Moist Heat or Steam Sterilization


[18257200043712]

Moist Heat or Steam Sterilization


[18257200043712]

Moist Heat or Steam Sterilization


[18257200043712]

Moist Heat or Steam Sterilization


[18257200043712]

Moist Heat or Steam Sterilization


[18257200043712]

Moist Heat or Steam Sterilization


[18257200043712]

Moist Heat or Steam Sterilization


[18257200043712]

Moist Heat or Steam Sterilization


[18257200043712]

Moist Heat or Steam Sterilization


[18257200043712]

Moist Heat or Steam Sterilization


[18257200043712]

Moist Heat or Steam Sterilization


[18257200043712]

Moist Heat or Steam Sterilization


[18257200043712]

Moist Heat or Steam Sterilization


[18257200043712]

Moist Heat or Steam Sterilization


[18257200043712]

Moist Heat or Steam Sterilization


[18257200043712]

Moist Heat or Steam Sterilization


[18257200043712]

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 AL]

18257200043743PILLAR AL SPACER 34X28X22, 12DEG LORDOTIC
18257200043736PILLAR AL SPACER 34X28X22, 12DEG LORDOTIC
18257200043729PILLAR AL SPACER 34X28X20, 12DEG LORDOTIC
18257200043712PILLAR AL SPACER 34X28X18, 12DEG LORDOTIC
18257200043705PILLAR AL SPACER 34X28X16, 12DEG LORDOTIC
18257200043699PILLAR AL SPACER 34X28X14, 12DEG LORDOTIC
18257200043682PILLAR AL SPACER 34X28X12, 12DEG LORDOTIC
18257200043675PILLAR AL SPACER 34X28X22, 7DEG LORDOTIC
18257200043668PILLAR AL SPACER 34X28X20, 7DEG LORDOTIC
18257200043651PILLAR AL SPACER 34X28X18, 7DEG LORDOTIC
18257200043644PILLAR AL SPACER 34X28X16, 7DEG LORDOTIC
18257200043637PILLAR AL SPACER 34X28X14, 7DEG LORDOTIC
18257200043620PILLAR AL SPACER 34X28X12, 7DEG LORDOTIC
18257200043613PILLAR AL SPACER 34X28X10, 7DEG LORDOTIC
18257200043606PILLAR AL 20MM 0DEG 34MM X 28MM, 0DEG
18257200043590PILLAR AL 18MM 0DEG 34MM X 28MM, 0DEG
18257200043583PILLAR AL 16MM 0DEG 34MM X 28MM, 0DEG
18257200043576PILLAR AL 14MM 0DEG 34MM X 28MM, 0DEG
18257200043569PILLAR AL 12MM 0DEG 34MM X 28MM, 0DEG
18257200043552PILLAR AL 10MM 0DEG 34MM X 28MM, 0DEG
18257200043545PILLAR AL 8MM 0DEG 34MM X 28MM, 0DEG
18257200043491PILLAR AL SPACER 30X24X24, 12DEG LORDOTIC
18257200043484PILLAR AL SPACER 30X24X22, 12DEG LORDOTIC
18257200043477PILLAR AL SPACER 30X24X20, 12DEG LORDOTIC
18257200043460PILLAR AL SPACER 30X24X18, 12DEG LORDOTIC
18257200043453PILLAR AL SPACER 30X24X16, 12DEG LORDOTIC
18257200043446PILLAR AL SPACER 30X24X14, 12DEG LORDOTIC
18257200043439PILLAR AL SPACER 30X24X12, 12DEG LORDOTIC
18257200043415PILLAR AL SPACER 30X24X 22, 7DEG LORDOTIC
18257200043408PILLAR AL SPACER 30X24X20, 7DEG LORDOTIC
18257200043392PILLAR AL SPACER 30X24X18, 7DEG LORDOTIC
18257200043385PILLAR AL SPACER 30X24X16, 7DEG LORDOTIC
18257200043378PILLAR AL SPACER 30X24X14, 7DEG LORDOTIC
18257200043361PILLAR AL SPACER 30X24X12, 7DEG LORDOTIC
18257200043354PILLAR AL SPACER 30X24X10, 7DEG LORDOTIC
18257200043347PILLAR AL SPACER 30X24X18 PARALLEL
18257200043330PILLAR AL SPACER 30X24X16 PARALLEL
18257200043323PILLAR AL SPACER 30X24X14 PARALLEL
18257200043316PILLAR AL SPACER 30X24X12 PARALLEL
18257200043309PILLAR AL SPACER 30X24X10 PARALLEL
18257200043293PILLAR AL SPACER 30X24X8 PARALLEL
18257200043286PILLAR AL 24MM X 12DEG 26MM X 20MM, 12DEG LORDOTIC
18257200043279PILLAR AL 22MM X 12DEG 26MM X 20MM, 12DEG LORDOTIC
18257200043262PILLAR AL 20MM X 12DEG 26MM X 20MM, 12DEG LORDOTIC
18257200043255PILLAR AL 18MM X 12DEG 26MM X 20MM, 12DEG LORDOTIC
18257200043248PILLAR AL 16MM X 12DEG 26MM X 20MM, 12DEG LORDOTIC
18257200043231PILLAR AL 14MM X 12DEG 26MM X 20MM, 12DEG LORDOTIC
18257200043224PILLAR AL 12MM X 12DEG 26MM X 20MM, 12DEG LORDOTIC
18257200043217PILLAR AL 10MM X 12DEG 26MM X 20MM, 12DEG LORDOTIC
18257200043200PILLAR AL SPACER 26X20X20, 7DEG LORDOTIC

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