Neo Medical Pedicle screw kit SC-50-35-PE

GUDID 07640177820013

PEDICLE SCREW KIT 2x(Ø5.0 x 35mm)

Neo Medical SA

Bone-screw internal spinal fixation system, sterile

• Primary Device ID: 07640177820013
• NIH Device Record Key: 584098b8-44a7-4d5c-bd95-e4488221e7a3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Neo Medical Pedicle screw kit
• Version Model Number: SC-50-35-PE
• Catalog Number: SC-50-35-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: 5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 35 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640177820013 [Primary]
HIBCC	B206SC5035PE0 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171582

FDA Product Code

• NKB: Thoracolumbosacral Pedicle Screw System

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: 2017-10-27

On-Brand Devices [Neo Medical Pedicle screw kit]

• B206RD0300ST0: Rod kit straight 300 mm (2x)
• B206RD0200ST0: Rod kit straight 200 mm (2x)
• B206RD0160ST0: Rod kit straight 160 mm (2x)
• B206RD0130ST0: Rod kit straight 130 mm (2x)
• B206RD0100ST0: Rod kit straight 100 mm (2x)
• B206RD0090ST0: Rod kit straight 90 mm (2x)
• B206RD0080ST0: Rod kit straight 80 mm (2x)
• B206RD0070ST0: Rod kit straight 70 mm (2x)
• B206RD0060ST0: Rod kit straight 60 mm (2x)
• B206RD0050ST0: Rod kit straight 50 mm (2x)
• B206RD0040ST0: Rod kit straight 40 mm (2x)
• B206RD0035ST0: Rod kit straight 35 mm (2x)
• B206RD0030ST0: Rod kit straight 30 mm (2x)
• B206RD0100PB0: Rod kit pre-bent 100 mm (2x)
• B206RD0090PB0: Rod kit pre-bent 90 mm (2x)
• B206RD0080PB0: Rod kit pre-bent 80 mm (2x)
• B206RD0070PB0: Rod kit pre-bent 70 mm (2x)
• B206RD0060PB0: Rod kit pre-bent 60 mm (2x)
• B206RD0050PB0: Rod kit pre-bent 50 mm (2x)
• B206RD0040PB0: Rod kit pre-bent 40 mm (2x)
• B206RD0040SB0: Rod kit S1/L5 40 mm (2x)
• B206RD0030SB0: Rod kit S1/L5 30 mm (2x)
• B206SC7055PE0: Pedicle screw kit 2x(Ø7.0 x 55mm)
• B206SC7050PE0: Pedicle screw kit 2x(Ø7.0 x 50mm)
• B206SC7045PE0: Pedicle screw kit 2x(Ø7.0 x 45mm)
• B206SC7040PE0: Pedicle screw kit 2x(Ø7.0 x 40mm)
• B206SC7035PE0: Pedicle screw kit 2x(Ø7.0 x 35mm)
• B206SC6055PE0: Pedicle screw kit 2x(Ø6.0 x 55mm)
• B206SC6050PE0: Pedicle screw kit 2x(Ø6.0 x 50mm)
• B206SC6045PE0: Pedicle screw kit 2x(Ø6.0 x 45mm)
• B206SC6040PE0: Pedicle screw kit 2x(Ø6.0 x 40mm)
• B206SC6035PE0: Pedicle screw kit 2x(Ø6.0 x 35mm)
• B206SC5050PE0: Pedicle screw kit 2x(Ø5.0 x 50mm)
• 07640177820037: Pedicle screw kit 2x(Ø5.0 x 45mm)
• 07640177820020: Pedicle screw kit 2x(Ø5.0 x 40mm)
• 07640177820013: PEDICLE SCREW KIT 2x(Ø5.0 x 35mm)
• 07640177820501: Universal T-Handle
• 07640177821201: Persuader
• 17640177821260: Granite Screw Guide (US only) (2x)