PILLAR PL

GUDID 18257200039616

PILLAR PL SPACER 11X33X10 PARALLEL

ORTHOFIX INC.

Metallic spinal interbody fusion cage
Primary Device ID18257200039616
NIH Device Record Key4ecc09fb-033d-44ef-b0e0-543c79bff5cf
Commercial Distribution StatusIn Commercial Distribution
Brand NamePILLAR PL
Version Model Number45-6610
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
GS118257200039616 [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

[18257200039616]

Moist Heat or Steam Sterilization

[18257200039616]

Moist Heat or Steam Sterilization

[18257200039616]

Moist Heat or Steam Sterilization

[18257200039616]

Moist Heat or Steam Sterilization

[18257200039616]

Moist Heat or Steam Sterilization

[18257200039616]

Moist Heat or Steam Sterilization

[18257200039616]

Moist Heat or Steam Sterilization

[18257200039616]

Moist Heat or Steam Sterilization

[18257200039616]

Moist Heat or Steam Sterilization

[18257200039616]

Moist Heat or Steam Sterilization

[18257200039616]

Moist Heat or Steam Sterilization

[18257200039616]

Moist Heat or Steam Sterilization

[18257200039616]

Moist Heat or Steam Sterilization

[18257200039616]

Moist Heat or Steam Sterilization

[18257200039616]

Moist Heat or Steam Sterilization

[18257200039616]

Moist Heat or Steam Sterilization

[18257200039616]

Moist Heat or Steam Sterilization

[18257200039616]

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 PL]

18257200081301PILLAR PL PEEK PARTIAL VBR SYSTEM, IMPLANT/INSTRUMENT CASE (45-0014)
18257200081288PILLAR PL VBR SYSTEM, 11MM X 27MM IMPLANTS AND TRIALS (46-0010)
18257200081264PILLAR PL (45-9097)
18257200041312FERRIS-SMITH RONGUERS: 4.0 X 10MM UP-ANGLE
18257200041305FERRIS-SMITH RONGUERS: 4.0 X 10MM STRAIGHT
18257200041299FERRIS-SMITH RONGUERS: 2.5 X 10MM STRAIGHT
18257200041282PILLAR PL TRIAL 11X33X16 PARALLEL
18257200041275PILLAR PL TRIAL 11X33X15 PARALLEL
18257200041268PILLAR PL TRIAL 11X33X14 PARALLEL
18257200041251PILLAR PL TRIAL 11X33X13 PARALLEL
18257200041244PILLAR PL TRIAL 11X33X12 PARALLEL
18257200041237PILLAR PL TRIAL 11X33X11 PARALLEL
18257200041220PILLAR PL TRIAL 11X33X10 PARALLEL
18257200041213PILLAR PL TRIAL 11X33X9 PARALLEL
18257200041206PILLAR PL TRIAL 11X33X8 PARALLEL
18257200041190PILLAR PL TRIAL 11X33X7 PARALLEL
18257200041183PILLAR PL TRIAL 11X33X6 PARALLEL
18257200041176SYPERT LARGE RONGUERS
18257200041169SYPERT SMALL RONGUERS
18257200041152PILLAR PL TRIAL 11X27X16, 8DEG LORDOTIC
18257200041145PILLAR PL TRIAL 11X27X15, 8DEG LORDOTIC
18257200041138PILLAR PL TRIAL 11X27X14, 8DEG LORDOTIC
18257200041121PILLAR PL TRIAL 11X27X13, 8DEG LORDOTIC
18257200041114PILLAR PL TRIAL 11X27X12, 8DEG LORDOTIC
18257200041107PILLAR PL TRIAL 11X27X11, 8DEG LORDOTIC
18257200041091PILLAR PL TRIAL 11X27X10, 8DEG LORDOTIC
18257200041084PILLAR PL TRIAL 11X27X9, 8DEG LORDOTIC
18257200041077PILLAR PL TRIAL 11X27X8, 8DEG LORDOTIC
18257200041060PILLAR PL TRIAL 11X27X7, 8DEG LORDOTIC
18257200041053PILLAR PL TRIAL 11X27X6, 8DEG LORDOTIC
18257200041046WIDE CHISEL
18257200041039NARROW CHISEL
18257200041022PILLAR PL TRIAL 11X27X16 PARALLEL
18257200041015PILLAR PL TRIAL 11X27X15 PARALLEL
18257200041008PILLAR PL TRIAL 11X27X14 PARALLEL
18257200040995PILLAR PL TRIAL 11X27X13 PARALLEL
18257200040988PILLAR PL TRIAL 11X27X12 PARALLEL
18257200040971PILLAR PL TRIAL 11X27X11 PARALLEL
18257200040964PILLAR PL TRIAL 11X27X10 PARALLEL
18257200040957PILLAR PL TRIAL 11X27X9 PARALLEL
18257200040940PILLAR PL TRIAL 11X27X8 PARALLEL
18257200040933PILLAR PL TRIAL 11X27X7 PARALLEL
18257200040926PILLAR PL TRIAL 11X27X6 PARALLEL
18257200040483PILLAR PL TRIAL 9X23X16, 8DEG LORDOTIC
18257200040476PILLAR PL TRIAL 9X23X15, 8DEG LORDOTIC
18257200040469PILLAR PL TRIAL 9X23X14, 8DEG LORDOTIC
18257200040452PILLAR PL TRIAL 9X23X13, 8DEG LORDOTIC
18257200040445PILLAR PL TRIAL 9X23X12, 8DEG LORDOTIC
18257200040438PILLAR PL TRIAL 9X23X11, 8DEG LORDOTIC
18257200040421PILLAR PL TRIAL 9X23X10, 8DEG LORDOTIC
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