True Tulip Spinal Fixation System

GUDID B50620593085401

5.5 mm x 35 mm True MIS Pedicle Screw

INNOVATIVE SURGICAL DESIGNS

Bone-screw internal spinal fixation system, sterile
Primary Device IDB50620593085401
NIH Device Record Keyf7dcdc18-9e01-46db-8c60-bce2f1892e4b
Commercial Distribution StatusIn Commercial Distribution
Brand NameTrue Tulip Spinal Fixation System
Version Model Number205-9-308-540
Company DUNS078306079
Company NameINNOVATIVE SURGICAL DESIGNS
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB50620593085401 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKBThoracolumbosacral Pedicle Screw System

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[B50620593085401]

Radiation Sterilization


[B50620593085401]

Radiation Sterilization


[B50620593085401]

Radiation Sterilization


[B50620593085401]

Radiation Sterilization


[B50620593085401]

Radiation Sterilization


[B50620593085401]

Radiation Sterilization


[B50620593085401]

Radiation Sterilization


[B50620593085401]

Radiation Sterilization


[B50620593085401]

Radiation Sterilization


[B50620593085401]

Radiation Sterilization


[B50620593085401]

Radiation Sterilization


[B50620593085401]

Radiation Sterilization


[B50620593085401]

Radiation Sterilization


[B50620593085401]

Radiation Sterilization


[B50620593085401]

Radiation Sterilization


[B50620593085401]

Radiation Sterilization


[B50620593085401]

Radiation Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-02-19
Device Publish Date2020-02-11

On-Brand Devices [True Tulip Spinal Fixation System]

B506S205933854001MIS Straight Titanium Rods, 5.5 mm x 400 mm
B506S205933853501MIS Straight Titanium Rods, 5.5 mm x 350 mm
B506S205933853001MIS Straight Titanium Rods, 5.5 mm x 300 mm
B506S205933852501MIS Straight Titanium Rods, 5.5 mm x 250 mm
B506S205933852001MIS Straight Titanium Rods, 5.5 mm x 200 mm
B506S205933851501MIS Straight Titanium Rods, 5.5 mm x 150 mm
B506S205933851151MIS Straight Titanium Rods, 5.5 mm x 115 mm
B506S205933851051MIS Straight Titanium Rods, 5.5 mm x 105 mm
B506S205933850951MIS Straight Titanium Rods, 5.5 mm x 95 mm
B506S205933850851MIS Straight Titanium Rods, 5.5 mm x 85 mm
B506S205933850751MIS Straight Titanium Rods, 5.5 mm x 75 mm
B506S205933850651MIS Straight Titanium Rods, 5.5 mm x 65 mm
B506S205933850601MIS Straight Titanium Rods, 5.5 mm x 60 mm
B506S205933850551MIS Straight Titanium Rods, 5.5 mm x 55 mm
B506S205933850501MIS Straight Titanium Rods, 5.5 mm x 50 mm
B506S205933850451MIS Straight Titanium Rods, 5.5 mm x 45 mm
B506S205933850401MIS Straight Titanium Rods, 5.5 mm x 40 mm
B506S205933850351MIS Straight Titanium Rods, 5.5 mm x 35 mm
B506S205933850301MIS Straight Titanium Rods, 5.5 mm x 30 mm
B506L205933851151MIS Lordotic Titanium Rods, 5.5 mm x 115 mm
B506L205933851051MIS Lordotic Titanium Rods, 5.5 mm x 105 mm
B506L205933850951MIS Lordotic Titanium Rods, 5.5 mm x 95 mm
B506L205933850851MIS Lordotic Titanium Rods, 5.5 mm x 85 mm
B506L205933850751MIS Lordotic Titanium Rods, 5.5 mm x 75 mm
B506L205933850651MIS Lordotic Titanium Rods, 5.5 mm x 65 mm
B506L205933850601MIS Lordotic Titanium Rods, 5.5 mm x 60 mm
B506L205933850551MIS Lordotic Titanium Rods, 5.5 mm x 55 mm
B506L205933850501MIS Lordotic Titanium Rods, 5.5 mm x 50 mm
B506L205933850451MIS Lordotic Titanium Rods, 5.5 mm x 45 mm
B506L205933850401MIS Lordotic Titanium Rods, 5.5 mm x 40 mm
B506L205933850351MIS Lordotic Titanium Rods, 5.5 mm x 35 mm
B506L205933850301MIS Lordotic Titanium Rods, 5.5 mm x 30 mm
B506205930875017.5 mm x 50 mm True MIS Pedicle Screw
B506205930874517.5 mm x 45 mm True MIS Pedicle Screw
B506205930874017.5 mm x 40 mm True MIS Pedicle Screw
B506205930873517.5 mm x 35 mm True MIS Pedicle Screw
B506205930865016.5 mm x 50 mm True MIS Pedicle Screw
B506205930864516.5 mm x 45 mm True MIS Pedicle Screw
B506205930864016.5 mm x 40 mm True MIS Pedicle Screw
B506205930863516.5 mm x 35 mm True MIS Pedicle Screw
B506205930855015.5 mm x 50 mm True MIS Pedicle Screw
B506205930854515.5 mm x 45 mm True MIS Pedicle Screw
B506205930854015.5 mm x 35 mm True MIS Pedicle Screw
B506205930853515.5 mm x 35 mm True MIS Pedicle Screw

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