Polyaxial Pedicle Screw

GUDID 07290014064881

Polyaxial Pedicle Screw Cannulated, Torx Setscrew, Grooved 6.5x45 mm

PREMIA SPINE LTD

Bone-screw internal spinal fixation system, sterile

• Primary Device ID: 07290014064881
• NIH Device Record Key: ff745e34-2ac9-45d8-b6e6-065fa4c615e7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Polyaxial Pedicle Screw
• Version Model Number: 86131
• 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: 45 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 6.5 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 22 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290014064881 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150380

FDA Product Code

• MNH: Orthosis, Spondylolisthesis Spinal Fixation

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-12-04

On-Brand Devices [Polyaxial Pedicle Screw]

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• 07290014080812: Poly. Pedicle Screw Cann.,Torx SS, Gr.7.5x25 mm
• 07290014080805: Poly. Pedicle Screw Cann.,Torx SS, Gr.6.5x30 mm
• 07290014080799: Poly. Pedicle Screw Cann.,Torx SS, Gr.6.5x25 mm
• 07290014080683: Poly. Pedicle Screw Cann.,Torx SS, Gr.7.5x35 mm
• 07290014080492: Poly. Pedicle Screw Cann.,Torx SS, Gr.5.5x55 mm
• 07290014080485: Poly. Pedicle Screw Cann.,Torx SS, Gr.5.5x50 mm
• 07290014080478: Poly. Pedicle Screw Cann.,Torx SS, Gr.5.5x45 mm
• 07290014080461: Poly. Pedicle Screw Cann.,Torx SS, Gr.5.5x40 mm
• 07290014080454: Poly. Pedicle Screw Cann.,Torx SS, Gr.5.5x35 mm
• 07290014080447: Poly. Pedicle Screw Cann.,Torx SS, Gr.5.5x30 mm
• 07290014080430: Poly. Pedicle Screw Cann.,Torx SS, Gr.5.5x25 mm
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• 07290014064942: Polyaxial Pedicle Screw Cannulated, Torx Setscrew, Grooved 7.5x55 mm
• 07290014064935: Polyaxial Pedicle Screw Cannulated, Torx Setscrew, Grooved 7.5x50 mm
• 07290014064928: Polyaxial Pedicle Screw Cannulated, Torx Setscrew, Grooved 7.5x45 mm
• 07290014064911: Polyaxial Pedicle Screw Cannulated, Torx Setscrew, Grooved 7.5x40 mm
• 07290014064904: Polyaxial Pedicle Screw Cannulated, Torx Setscrew, Grooved 6.5x55 mm
• 07290014064898: Polyaxial Pedicle Screw Cannulated, Torx Setscrew, Grooved 6.5x50 mm
• 07290014064881: Polyaxial Pedicle Screw Cannulated, Torx Setscrew, Grooved 6.5x45 mm
• 07290014064874: Polyaxial Pedicle Screw Cannulated, Torx Setscrew, Grooved 6.5x40 mm
• 07290014080867: Cannulated Polyaxial Pedicle Screw 7.5x60 mm used for fixation of spinal implants to the vertebr
• 07290014080850: Cannulated Polyaxial Pedicle Screw 6.5x60 mm used for fixation of spinal implants to the vertebr
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