CONSTRUX - PEEK VBR 48-0010

GUDID 18257200081387

PILLAR AL (48-0010)

ORTHOFIX INC.

Metallic spinal fusion cage, sterile
Primary Device ID18257200081387
NIH Device Record Key5d8ea5a0-ce71-4618-a5c3-620710d02505
Commercial Distribution StatusIn Commercial Distribution
Brand NameCONSTRUX - PEEK VBR
Version Model Number450217-0001
Catalog Number48-0010
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
Email[email protected]

Device Identifiers

Device Issuing AgencyDevice ID
GS118257200081387 [Primary]

FDA Product Code

MQPSpinal vertebral body replacement device

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[18257200081387]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-02-11
Device Publish Date2020-02-03

On-Brand Devices [CONSTRUX - PEEK VBR]

18257200081257CONSTRUX PEEK VBR SYSTEM, IMPLANT AND INSTRUMENT CASE (45-0011)
18257200081240CONSTRUX PEEK VBR SYSTEM, INSTRUMENT CASE 2 (45-0020)
18257200081233CONSTRUX PEEK VBR IMPLANT SYSTEM - CASE 1 (45-0010)
18257200043071PILLAR AL TRIAL 34X28X24, 12DEG LORDOTIC
18257200043064PILLAR AL TRIAL 34X28X22, 12DEG LORDOTIC
18257200043057PILLAR AL TRIAL 34X28X20, 12DEG LORDOTIC
18257200043040PILLAR AL TRIAL 34X28X18, 12DEG LORDOTIC
18257200043033PILLAR AL TRIAL 34X28X16, 12DEG LORDOTIC
18257200043026PILLAR AL TRIAL 34X28X14, 12DEG LORDOTIC
18257200043019PILLAR AL TRIAL 34X28X12, 12DEG LORDOTIC
18257200043002PILLAR AL 34MM X 28MM X 22MM TRIAL 7DEG LORDOTIC
18257200042999PILLAR AL 34MM X 28MM X 20MM TRIAL 7DEG LORDOTIC
18257200042982PILLAR AL 34MM X 28MM X 18MM TRIAL 7DEG LORDOTIC
18257200042975PILLAR AL 34MM X 28MM X 16MM TRIAL 7DEG LORDOTIC
18257200042968PILLAR AL 34MM X 28MM X 14MM TRIAL 7DEG LORDOTIC
18257200042951PILLAR AL 34MM X 28MM X 12MM TRIAL 7DEG LORDOTIC
18257200042944PILLAR AL 24MM X 28MM X 10MM TRIAL 7DEG LORDOTIC
18257200042920PILLAR AL TRIAL 34X28X20 0DEG 30MM X 34MMX 20MM,0DEG LORDOTIC
18257200042913PILLAR AL TRIAL 34X28X18 0DEG 30MM X 34MMX 18MM,0DEG LORDOTIC
18257200042906PILLAR AL TRIAL 34X28X16 0DEG 30MM X 34MMX 16MM,0DEG LORDOTIC
18257200042890PILLAR AL TRIAL 34X28X14 0DEG 30MM X 34MMX 14MM,0DEG LORDOTIC
18257200042883PILLAR AL TRIAL 34X28X12 0DEG 30MM X 34MMX 12MM,0DEG LORDOTIC
18257200042876PILLAR AL TRIAL 34X28X10 0DEG 30MM X 34MMX 10MM,0DEG LORDOTIC
18257200042869PILLAR AL TRIAL 34X28X8 0DEG 30MM X 34MMX 8MM,0DEG LORDOTIC
18257200042852PILLAR AL TRIAL 30X24X24, 12DEG LORDOTIC
18257200042845PILLAR AL TRIAL 30X24X22, 12DEG LORDOTIC
18257200042838PILLAR AL TRIAL 30X24X20, 12DEG LORDOTIC
18257200042821PILLAR AL TRIAL 30X24X18, 12DEG LORDOTIC
18257200042814PILLAR AL TRIAL 30X24X16, 12DEG LORDOTIC
18257200042807PILLAR AL TRIAL 30X24X14, 12DEG LORDOTIC
18257200042791PILLAR AL TRIAL 30X24X12, 12DEG LORDOTIC
18257200042784PILLAR AL TRIAL 30X24X22, 7DEG LORDOTIC
18257200042777PILLAR AL TRIAL 30X24X20, 7DEG LORDOTIC
18257200042760PILLAR AL TRIAL 30X24X18, 7DEG LORDOTIC
18257200042753PILLAR AL TRIAL 30X24X16, 7DEG LORDOTIC
18257200042746PILLAR AL TRIAL 30X24X14, 7DEG LORDOTIC
18257200042739PILLAR AL TRIAL 30X24X12, 7DEG LORDOTIC
18257200042722PILLAR AL TRIAL 30X24X10, 7DEG LORDOTIC
18257200042715PILLAR AL TRIAL 30X24X18 PARALLEL
18257200042708PILLAR AL TRIAL 30X24X16 PARALLEL
18257200042692PILLAR AL TRIAL 30X24X14 PARALLEL
18257200042685PILLAR AL TRIAL 30X24X12 PARALLEL
18257200042678PILLAR AL TRIAL 30X24X10 PARALLEL
18257200042661PILLAR AL TRIAL 30X24X8 PARALLEL
18257200042654PILLAR AL TRIAL 26X20X24 12DEG 26MM X 20MMX 24MM,12DEG LORDOTIC
18257200042647PILLAR AL TRIAL 26X20X22 12DEG 26MM X 20MMX 22MM,12DEG LORDOTIC
18257200042630PILLAR AL TRIAL 26X20X20 12DEG 26MM X 20MMX 20MM,12DEG LORDOTIC
18257200042623PILLAR AL TRIAL 26X20X18 12DEG 26MM X 20MMX 18MM,12DEG LORDOTIC
18257200042616PILLAR AL TRIAL 26X20X16 12DEG 26MM X 20MMX 16MM,12DEG LORDOTIC
18257200042609PILLAR AL TRIAL 26X20X14 12DEG 26MM X 20MMX 14MM,12DEG LORDOTIC

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