Neo Medical Pedicle Screw System

GUDID 07640177821027

Pedicle screw kit 2x(Ø6.0 x 30mm)

Neo Medical SA

Spinal bone screw, non-bioabsorbable

Primary Device ID	07640177821027
NIH Device Record Key	37b47d03-67af-4950-9c00-5477aad1872a
Commercial Distribution Status	In Commercial Distribution
Brand Name	Neo Medical Pedicle Screw System
Version Model Number	SC-60-30-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	6 Millimeter
Length	30 Millimeter
Outer Diameter	6 Millimeter
Length	30 Millimeter
Outer Diameter	6 Millimeter
Length	30 Millimeter
Outer Diameter	6 Millimeter
Length	30 Millimeter
Outer Diameter	6 Millimeter
Length	30 Millimeter
Outer Diameter	6 Millimeter
Length	30 Millimeter
Outer Diameter	6 Millimeter
Length	30 Millimeter
Outer Diameter	6 Millimeter
Length	30 Millimeter
Outer Diameter	6 Millimeter
Length	30 Millimeter
Outer Diameter	6 Millimeter
Length	30 Millimeter
Outer Diameter	6 Millimeter
Length	30 Millimeter
Outer Diameter	6 Millimeter
Length	30 Millimeter
Outer Diameter	6 Millimeter
Length	30 Millimeter
Outer Diameter	6 Millimeter
Length	30 Millimeter
Outer Diameter	6 Millimeter
Length	30 Millimeter
Outer Diameter	6 Millimeter
Length	30 Millimeter
Outer Diameter	6 Millimeter
Length	30 Millimeter
Outer Diameter	6 Millimeter
Length	30 Millimeter
Outer Diameter	6 Millimeter
Length	30 Millimeter
Outer Diameter	6 Millimeter
Length	30 Millimeter
Outer Diameter	6 Millimeter
Length	30 Millimeter
Outer Diameter	6 Millimeter
Length	30 Millimeter
Outer Diameter	6 Millimeter
Length	30 Millimeter
Outer Diameter	6 Millimeter
Length	30 Millimeter
Outer Diameter	6 Millimeter
Length	30 Millimeter
Outer Diameter	6 Millimeter
Length	30 Millimeter
Outer Diameter	6 Millimeter
Length	30 Millimeter

Operating and Storage Conditions

Handling Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Handling Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Handling Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Handling Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Handling Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Handling Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Handling Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Handling Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Handling Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Handling Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Handling Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Handling Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Handling Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Handling Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Handling Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Handling Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Handling Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Handling Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Handling Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Handling Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Handling Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Handling Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Handling Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Handling Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Handling Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Handling Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Handling Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640177821027 [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
07640177821096	Screw Guide Remover