Cannulated Tapered Pedicle Screw

GUDID 07290115933925

Cannulated Tapered Pedicle Screw 7.5X60[mm] used for fixation of spinal implants to the vertebrae.

PREMIA SPINE LTD

Bone-screw internal spinal fixation system, sterile

• Primary Device ID: 07290115933925
• NIH Device Record Key: 4356648e-572d-4ce5-a54a-7a7dd714ced2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cannulated Tapered Pedicle Screw
• Version Model Number: 88692
• Company DUNS: 649220779
• Company Name: PREMIA SPINE LTD
• 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 Dimensions

• Length: 60 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 7.5 Millimeter

Operating and Storage Conditions

• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 22 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290115933925 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231844

FDA Product Code

• NKB: Thoracolumbosacral Pedicle Screw System

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-12-20
• Device Publish Date: 2023-12-12

On-Brand Devices [Cannulated Tapered Pedicle Screw]

• 07290115933925: Cannulated Tapered Pedicle Screw 7.5X60[mm] used for fixation of spinal implants to the vertebra
• 07290115933918: Cannulated Tapered Pedicle Screw 7.5X55[mm] used for fixation of spinal implants to the vertebra
• 07290115933901: Cannulated Tapered Pedicle Screw 7.5X50[mm] used for fixation of spinal implants to the vertebra
• 07290115933895: Cannulated Tapered Pedicle Screw 7.5X45[mm] used for fixation of spinal implants to the vertebra
• 07290115933888: Cannulated Tapered Pedicle Screw 7.5X40[mm] used for fixation of spinal implants to the vertebra
• 07290115933871: Cannulated Tapered Pedicle Screw 7.5X35[mm] used for fixation of spinal implants to the vertebra
• 07290115933864: Cannulated Tapered Pedicle Screw 7.5X30[mm] used for fixation of spinal implants to the vertebra
• 07290115933857: Cannulated Tapered Pedicle Screw 6.5X60[mm] used for fixation of spinal implants to the vertebra
• 07290115933840: Cannulated Tapered Pedicle Screw 6.5X55[mm] used for fixation of spinal implants to the vertebra
• 07290115933833: Cannulated Tapered Pedicle Screw 6.5X50[mm] used for fixation of spinal implants to the vertebra
• 07290115933826: Cannulated Tapered Pedicle Screw 6.5X45[mm] used for fixation of spinal implants to the vertebra
• 07290115933819: Cannulated Tapered Pedicle Screw 6.5X40[mm] used for fixation of spinal implants to the vertebra
• 07290115933802: Cannulated Tapered Pedicle Screw 6.5X35[mm] used for fixation of spinal implants to the vertebra
• 07290115933796: Cannulated Tapered Pedicle Screw 6.5X30[mm] used for fixation of spinal implants to the vertebra
• 07290115933789: Cannulated Tapered Pedicle Screw 5.5X60[mm] used for fixation of spinal implants to the vertebra
• 07290115933772: Cannulated Tapered Pedicle Screw 5.5X55[mm] used for fixation of spinal implants to the vertebra
• 07290115933765: Cannulated Tapered Pedicle Screw 5.5X50[mm] used for fixation of spinal implants to the vertebra
• 07290115933758: Cannulated Tapered Pedicle Screw 5.5X45[mm] used for fixation of spinal implants to the vertebra
• 07290115933741: Cannulated Tapered Pedicle Screw 5.5X40[mm] used for fixation of spinal implants to the vertebra
• 07290115933734: Cannulated Tapered Pedicle Screw 5.5X35[mm] used for fixation of spinal implants to the vertebra