True Spinal Fixation System

GUDID B5061059309A101

10.0mm x 49mm True Tapered Pedicle Screw

INNOVATIVE SURGICAL DESIGNS

Bone-screw internal spinal fixation system, sterile
Primary Device IDB5061059309A101
NIH Device Record Key1732dcb4-b6b7-408a-af94-5870b4e2cb23
Commercial Distribution StatusIn Commercial Distribution
Brand NameTrue Spinal Fixation System
Version Model Number105-9-309-A10
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

Customer Support Contacts

Phone8123694252
Emailxx@xx.xx
Phone8123694252
Emailxx@xx.xx

Device Dimensions

Length49 Millimeter
Outer Diameter10 Millimeter
Length49 Millimeter
Outer Diameter10 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB5061059309A101 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MNIOrthosis, Spinal Pedicle Fixation

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[B5061059309A101]

Radiation Sterilization

[B5061059309A101]

Radiation Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-03-09

On-Brand Devices [True Spinal Fixation System]

B506S105933854001Straight Titanium Rods, 5.5mm x 400mm
B506S105933853501Straight Titanium Rods, 5.5mm x 350mm
B506S105933853001Straight Titanium Rods, 5.5mm x 300mm
B506S105933852501Straight Titanium Rods, 5.5mm x 250mm
B506S105933852001Straight Titanium Rods, 5.5mm x 200mm
B506S105933851501Straight Titanium Rods, 5.5mm x 150mm
B506S105933851151Straight Titanium Rods, 5.5mm x 115mm
B506S105933851051Straight Titanium Rods, 5.5mm x 105mm
B506S105933850951Straight Titanium Rods, 5.5mm x 95mm
B506S105933850851Straight Titanium Rods, 5.5mm x 85mm
B506S105933850751Straight Titanium Rods, 5.5mm x 75mm
B506S105933850651Straight Titanium Rods, 5.5mm x 65mm
B506S105933850601Straight Titanium Rods, 5.5mm x 60mm
B506S105933850551Straight Titanium Rods, 5.5mm x 55mm
B506S105933850501Straight Titanium Rods, 5.5mm x 50mm
B506S105933850451Straight Titanium Rods, 5.5mm x 45mm
B506S105933850401Straight Titanium Rods, 5.5mm x 40mm
B506S105933850351Straight Titanium Rods, 5.5mm x 35mm
B506S105933850301Straight Titanium Rods, 5.5mm x 30mm
B506N105933702147mm-65mm Sizing Trials
B506N105933701127mm-45mm Sizing Trials
B506N10593311Locking Cap - Single Pack
B506N1059331044Locking Cap - Four Pack
B506N105931015.5mm Supplemental Non-Disposable Instrument Tray
B506N1059303550150mm Starter Rod
B506N1059303547147mm Starter Rod
B506N1059303545145mm Starter Rod
B506N1059303542142mm Starter Rod
B506N1059303540140mm Starter Rod
B506N1059303537137mm Starter Rod
B506N1059303535135mm Starter Rod
B506N1059303532132mm Starter Rod
B506N1059303530130mm Starter Rod
B506N1059303527127mm Starter Rod
B506N1059303525125mm Starter Rod
B506N10593031051105mm Add-On Rod
B506N10593031001100mm Add-On Rod
B506N1059303095195mm Add-On Rod
B506N1059303090190mm Add-On Rod
B506N1059303085185mm Add-On Rod
B506N1059303080180mm Add-On Rod
B506N1059303075175mm Add-On Rod
B506N1059303072172mm Add-On Rod
B506N1059303070170mm Add-On Rod
B506N1059303067167mm Add-On Rod
B506N1059303065165mm Add-On Rod
B506N1059303062162mm Add-On Rod
B506N1059303060160mm Add-On Rod
B506N1059303057157mm Add-On Rod
B506N1059303055155mm Add-On Rod
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