True Spinal Fixation System

GUDID B5061059309645TT1

6.5mm x 45mm Noncannulated Pedicle Screw

INNOVATIVE SURGICAL DESIGNS

Bone-screw internal spinal fixation system, sterile

• Primary Device ID: B5061059309645TT1
• NIH Device Record Key: 9a49726d-32e0-4510-9f44-c0e2abca5340
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: True Spinal Fixation System
• Version Model Number: 105-9-309-645-TT
• Company DUNS: 078306079
• Company Name: INNOVATIVE SURGICAL DESIGNS
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B5061059309645TT1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181584

FDA Product Code

• NKB: Thoracolumbosacral Pedicle Screw System

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[B5061059309645TT1]

Radiation Sterilization

[B5061059309645TT1]

Radiation Sterilization

[B5061059309645TT1]

Radiation Sterilization

[B5061059309645TT1]

Radiation Sterilization

[B5061059309645TT1]

Radiation Sterilization

[B5061059309645TT1]

Radiation Sterilization

[B5061059309645TT1]

Radiation Sterilization

[B5061059309645TT1]

Radiation Sterilization

[B5061059309645TT1]

Radiation Sterilization

[B5061059309645TT1]

Radiation Sterilization

[B5061059309645TT1]

Radiation Sterilization

[B5061059309645TT1]

Radiation Sterilization

[B5061059309645TT1]

Radiation Sterilization

[B5061059309645TT1]

Radiation Sterilization

[B5061059309645TT1]

Radiation Sterilization

[B5061059309645TT1]

Radiation Sterilization

[B5061059309645TT1]

Radiation Sterilization

[B5061059309645TT1]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-11-19
• Device Publish Date: 2018-10-19

On-Brand Devices [True Spinal Fixation System]

• B506S105933854001: Straight Titanium Rods, 5.5mm x 400mm
• B506S105933853501: Straight Titanium Rods, 5.5mm x 350mm
• B506S105933853001: Straight Titanium Rods, 5.5mm x 300mm
• B506S105933852501: Straight Titanium Rods, 5.5mm x 250mm
• B506S105933852001: Straight Titanium Rods, 5.5mm x 200mm
• B506S105933851501: Straight Titanium Rods, 5.5mm x 150mm
• B506S105933851151: Straight Titanium Rods, 5.5mm x 115mm
• B506S105933851051: Straight Titanium Rods, 5.5mm x 105mm
• B506S105933850951: Straight Titanium Rods, 5.5mm x 95mm
• B506S105933850851: Straight Titanium Rods, 5.5mm x 85mm
• B506S105933850751: Straight Titanium Rods, 5.5mm x 75mm
• B506S105933850651: Straight Titanium Rods, 5.5mm x 65mm
• B506S105933850601: Straight Titanium Rods, 5.5mm x 60mm
• B506S105933850551: Straight Titanium Rods, 5.5mm x 55mm
• B506S105933850501: Straight Titanium Rods, 5.5mm x 50mm
• B506S105933850451: Straight Titanium Rods, 5.5mm x 45mm
• B506S105933850401: Straight Titanium Rods, 5.5mm x 40mm
• B506S105933850351: Straight Titanium Rods, 5.5mm x 35mm
• B506S105933850301: Straight Titanium Rods, 5.5mm x 30mm
• B506N1059337021: 47mm-65mm Sizing Trials
• B506N1059337011: 27mm-45mm Sizing Trials
• B506N10593311: Locking Cap - Single Pack
• B506N1059331044: Locking Cap - Four Pack
• B506N10593101: 5.5mm Supplemental Non-Disposable Instrument Tray
• B506N10593035501: 50mm Starter Rod
• B506N10593035471: 47mm Starter Rod
• B506N10593035451: 45mm Starter Rod
• B506N10593035421: 42mm Starter Rod
• B506N10593035401: 40mm Starter Rod
• B506N10593035371: 37mm Starter Rod
• B506N10593035351: 35mm Starter Rod
• B506N10593035321: 32mm Starter Rod
• B506N10593035301: 30mm Starter Rod
• B506N10593035271: 27mm Starter Rod
• B506N10593035251: 25mm Starter Rod
• B506N10593031051: 105mm Add-On Rod
• B506N10593031001: 100mm Add-On Rod
• B506N10593030951: 95mm Add-On Rod
• B506N10593030901: 90mm Add-On Rod
• B506N10593030851: 85mm Add-On Rod
• B506N10593030801: 80mm Add-On Rod
• B506N10593030751: 75mm Add-On Rod
• B506N10593030721: 72mm Add-On Rod
• B506N10593030701: 70mm Add-On Rod
• B506N10593030671: 67mm Add-On Rod
• B506N10593030651: 65mm Add-On Rod
• B506N10593030621: 62mm Add-On Rod
• B506N10593030601: 60mm Add-On Rod
• B506N10593030571: 57mm Add-On Rod
• B506N10593030551: 55mm Add-On Rod