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 ID: B50620593085401
• NIH Device Record Key: f7dcdc18-9e01-46db-8c60-bce2f1892e4b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: True Tulip Spinal Fixation System
• Version Model Number: 205-9-308-540
• 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	B50620593085401 [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

[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 Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-02-19
• Device Publish Date: 2020-02-11

On-Brand Devices [True Tulip Spinal Fixation System]

• B506S205933854001: MIS Straight Titanium Rods, 5.5 mm x 400 mm
• B506S205933853501: MIS Straight Titanium Rods, 5.5 mm x 350 mm
• B506S205933853001: MIS Straight Titanium Rods, 5.5 mm x 300 mm
• B506S205933852501: MIS Straight Titanium Rods, 5.5 mm x 250 mm
• B506S205933852001: MIS Straight Titanium Rods, 5.5 mm x 200 mm
• B506S205933851501: MIS Straight Titanium Rods, 5.5 mm x 150 mm
• B506S205933851151: MIS Straight Titanium Rods, 5.5 mm x 115 mm
• B506S205933851051: MIS Straight Titanium Rods, 5.5 mm x 105 mm
• B506S205933850951: MIS Straight Titanium Rods, 5.5 mm x 95 mm
• B506S205933850851: MIS Straight Titanium Rods, 5.5 mm x 85 mm
• B506S205933850751: MIS Straight Titanium Rods, 5.5 mm x 75 mm
• B506S205933850651: MIS Straight Titanium Rods, 5.5 mm x 65 mm
• B506S205933850601: MIS Straight Titanium Rods, 5.5 mm x 60 mm
• B506S205933850551: MIS Straight Titanium Rods, 5.5 mm x 55 mm
• B506S205933850501: MIS Straight Titanium Rods, 5.5 mm x 50 mm
• B506S205933850451: MIS Straight Titanium Rods, 5.5 mm x 45 mm
• B506S205933850401: MIS Straight Titanium Rods, 5.5 mm x 40 mm
• B506S205933850351: MIS Straight Titanium Rods, 5.5 mm x 35 mm
• B506S205933850301: MIS Straight Titanium Rods, 5.5 mm x 30 mm
• B506L205933851151: MIS Lordotic Titanium Rods, 5.5 mm x 115 mm
• B506L205933851051: MIS Lordotic Titanium Rods, 5.5 mm x 105 mm
• B506L205933850951: MIS Lordotic Titanium Rods, 5.5 mm x 95 mm
• B506L205933850851: MIS Lordotic Titanium Rods, 5.5 mm x 85 mm
• B506L205933850751: MIS Lordotic Titanium Rods, 5.5 mm x 75 mm
• B506L205933850651: MIS Lordotic Titanium Rods, 5.5 mm x 65 mm
• B506L205933850601: MIS Lordotic Titanium Rods, 5.5 mm x 60 mm
• B506L205933850551: MIS Lordotic Titanium Rods, 5.5 mm x 55 mm
• B506L205933850501: MIS Lordotic Titanium Rods, 5.5 mm x 50 mm
• B506L205933850451: MIS Lordotic Titanium Rods, 5.5 mm x 45 mm
• B506L205933850401: MIS Lordotic Titanium Rods, 5.5 mm x 40 mm
• B506L205933850351: MIS Lordotic Titanium Rods, 5.5 mm x 35 mm
• B506L205933850301: MIS Lordotic Titanium Rods, 5.5 mm x 30 mm
• B50620593087501: 7.5 mm x 50 mm True MIS Pedicle Screw
• B50620593087451: 7.5 mm x 45 mm True MIS Pedicle Screw
• B50620593087401: 7.5 mm x 40 mm True MIS Pedicle Screw
• B50620593087351: 7.5 mm x 35 mm True MIS Pedicle Screw
• B50620593086501: 6.5 mm x 50 mm True MIS Pedicle Screw
• B50620593086451: 6.5 mm x 45 mm True MIS Pedicle Screw
• B50620593086401: 6.5 mm x 40 mm True MIS Pedicle Screw
• B50620593086351: 6.5 mm x 35 mm True MIS Pedicle Screw
• B50620593085501: 5.5 mm x 50 mm True MIS Pedicle Screw
• B50620593085451: 5.5 mm x 45 mm True MIS Pedicle Screw
• B50620593085401: 5.5 mm x 35 mm True MIS Pedicle Screw
• B50620593085351: 5.5 mm x 35 mm True MIS Pedicle Screw