Neo Medical Pedicle Screw System

GUDID 07640177821058

Pedicle screw kit 2x(Ø8.0 x 40mm)

Neo Medical SA

Spinal bone screw, non-bioabsorbable

• Primary Device ID: 07640177821058
• NIH Device Record Key: 65ceb5d5-9fa0-435d-a21e-2405b2dce08a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Neo Medical Pedicle Screw System
• Version Model Number: SC-80-40-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: 40 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 40 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640177821058 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222256

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: 2
• Public Version Date: 2024-07-22
• Device Publish Date: 2023-01-20

On-Brand Devices [Neo Medical Pedicle Screw System]

• 07640177820679: Pedicle marker inserter
• 07640177821188: Single Use Pedicle marker (2x)
• 07640177821256: Persuader (US Only)
• 07640177821232: Ratchet T-Handle - 1/4", NS
• 07640177820884: Screwdriver Converter - Hudson, NS
• 07640177820877: Screwdriver Converter - AO, NS
• 07640177820860: Screwdriver Handle, NS
• 07640177820853: Ratchet Screwdriver 1/4", NS
• 07640177820815: Ratchet Handle - 1/4", NS
• 07640177820808: Screwdriver Adaptor - 1/4", NS
• 07640177820785: Screwdriver Adaptor - Hudson, NS
• 07640177820778: Ratchet Handle - Hudson, NS
• 07640177820433: Screw driver Kit
• 07640177820457: 1.5mm K-wire (1x2)
• 07640177821225: Rod kit pre-bent 45 mm (2x)
• 07640177821218: Rod kit pre-bent 35 mm (2x)
• 07640177821195: Pedicle screw kit 2x(Ø5.0 x 30mm)
• 07640177821072: Revision Guide
• 07640177821058: Pedicle screw kit 2x(Ø8.0 x 40mm)
• 07640177821041: Pedicle screw kit 2x(Ø8.0 x 35mm)
• 07640177821034: Pedicle screw kit 2x(Ø7.0 x 30mm)
• 07640177821027: Pedicle screw kit 2x(Ø6.0 x 30mm)
• 07640177820839: Iliac connector - 70 mm
• 07640177820822: Iliac connector - 40 mm