Non-Cannulated Polyaxial Pedicle Screw

GUDID 07290115931891

Non-Cannulated Polyaxial Pedicle Screw 6.5X35[mm] used for fixation of spinal implants to the vertebrae.

PREMIA SPINE LTD

Bone-screw internal spinal fixation system, sterile

• Primary Device ID: 07290115931891
• NIH Device Record Key: a588148d-6434-4987-83f5-be29e34ed0ee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Non-Cannulated Polyaxial Pedicle Screw
• Version Model Number: 88510
• 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: 35 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 6.5 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
• 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	07290115931891 [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: 2023-11-09
• Device Publish Date: 2023-11-01

On-Brand Devices [Non-Cannulated Polyaxial Pedicle Screw]

• 07290115933710: Non-Cannulated Polyaxial Pedicle Screw 7.5X25[mm] used for fixation of spinal implants to the ve
• 07290115933703: Non-Cannulated Polyaxial Pedicle Screw 6.5X25[mm] used for fixation of spinal implants to the ve
• 07290115933697: Non-Cannulated Polyaxial Pedicle Screw 5.5X25[mm] used for fixation of spinal implants to the ve
• 07290115932010: Non-Cannulated Polyaxial Pedicle Screw 7.5X60[mm] used for fixation of spinal implants to the ve
• 07290115932003: Non-Cannulated Polyaxial Pedicle Screw 7.5X55[mm] used for fixation of spinal implants to the ve
• 07290115931990: Non-Cannulated Polyaxial Pedicle Screw 7.5X50[mm] used for fixation of spinal implants to the ve
• 07290115931983: Non-Cannulated Polyaxial Pedicle Screw 7.5X45[mm] used for fixation of spinal implants to the ve
• 07290115931976: Non-Cannulated Polyaxial Pedicle Screw 7.5X40[mm] used for fixation of spinal implants to the ve
• 07290115931969: Non-Cannulated Polyaxial Pedicle Screw 7.5X35[mm] used for fixation of spinal implants to the ve
• 07290115931952: Non-Cannulated Polyaxial Pedicle Screw 7.5X30[mm] used for fixation of spinal implants to the ve
• 07290115931945: Non-Cannulated Polyaxial Pedicle Screw 6.5X60[mm] used for fixation of spinal implants to the ve
• 07290115931938: Non-Cannulated Polyaxial Pedicle Screw 6.5X55[mm] used for fixation of spinal implants to the ve
• 07290115931921: Non-Cannulated Polyaxial Pedicle Screw 6.5X50[mm] used for fixation of spinal implants to the ve
• 07290115931914: Non-Cannulated Polyaxial Pedicle Screw 6.5X45[mm] used for fixation of spinal implants to the ve
• 07290115931907: Non-Cannulated Polyaxial Pedicle Screw 6.5X40[mm] used for fixation of spinal implants to the ve
• 07290115931891: Non-Cannulated Polyaxial Pedicle Screw 6.5X35[mm] used for fixation of spinal implants to the ve
• 07290115931884: Non-Cannulated Polyaxial Pedicle Screw 6.5X30[mm] used for fixation of spinal implants to the ve
• 07290115931877: Non-Cannulated Polyaxial Pedicle Screw 5.5X60[mm] used for fixation of spinal implants to the ve
• 07290115931860: Non-Cannulated Polyaxial Pedicle Screw 5.5X55[mm] used for fixation of spinal implants to the ve
• 07290115931853: Non-Cannulated Polyaxial Pedicle Screw 5.5X50[mm] used for fixation of spinal implants to the ve
• 07290115931846: Non-Cannulated Polyaxial Pedicle Screw 5.5X45[mm] used for fixation of spinal implants to the ve
• 07290115931839: Non-Cannulated Polyaxial Pedicle Screw 5.5X40[mm] used for fixation of spinal implants to the ve
• 07290115931822: Non-Cannulated Polyaxial Pedicle Screw 5.5X35[mm] used for fixation of spinal implants to the ve
• 07290115931815: Non-Cannulated Polyaxial Pedicle Screw 5.5X30[mm] used for fixation of spinal implants to the ve