Neo Pedicle Screw System

GUDID 07640177820686

Pedicle screw kit 2x(Ø8.0 x 45mm)

Neo Medical SA

Bone-screw internal spinal fixation system, sterile

• Primary Device ID: 07640177820686
• NIH Device Record Key: e2e9121e-dcde-457d-bfa1-af1b3656b2f9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Neo Pedicle Screw System
• Version Model Number: SC-80-45-PE
• Company DUNS: 486778843
• Company Name: Neo Medical SA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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

• Outer Diameter: 8 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 45 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640177820686 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212489

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: 2021-12-06
• Device Publish Date: 2021-11-26

On-Brand Devices [Neo Pedicle Screw System]

• 07640177820846: Parallel rod connector
• 07640177820761: Rod kit straight 500 mm (1x) - CoCr
• 07640177820754: Rod kit straight 500 mm (1x) - Titanium
• 07640177820747: Iliac screw Ø8.0 x 100mm
• 07640177820730: Iliac screw Ø8.0 x 90mm
• 07640177820723: Iliac screw Ø8.0 x 80mm
• 07640177820716: Iliac screw Ø8.0 x 70mm
• 07640177820709: Pedicle screw kit 2x(Ø8.0 x 55mm)
• 07640177820693: Pedicle screw kit 2x(Ø8.0 x 50mm)
• 07640177820686: Pedicle screw kit 2x(Ø8.0 x 45mm)
• 07640177820563: Rod kit straight 400 mm (2x)
• 07640177820556: Pedicle screw kit 2x(Ø4.5 x 45mm)
• 07640177820549: Pedicle screw kit 2x(Ø4.5 x 40mm)
• 07640177820532: Pedicle screw kit 2x(Ø4.5 x 35mm)
• 07640177820525: Pedicle screw kit 2x(Ø4.5 x 30mm)