True Spinal Fixation System

GUDID B50610593097451

7.5mm x 45mm True Polyaxial Pedicle Screw

INNOVATIVE SURGICAL DESIGNS

Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile

• Primary Device ID: B50610593097451
• NIH Device Record Key: 3a4ae3a5-c645-441e-a560-2a1996c9768b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: True Spinal Fixation System
• Version Model Number: 105-9-309-745
• 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

Customer Support Contacts

• Phone: 8123694252
• Email: xx@xx.xx
• Phone: 8123694252
• Email: xx@xx.xx

Device Dimensions

• Length: 45 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 7.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B50610593097451 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133690

FDA Product Code

• MNH: Orthosis, Spondylolisthesis Spinal Fixation

Sterilization

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

[B50610593097451]

Radiation Sterilization

[B50610593097451]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-03-09

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