Neo Medical Pedicle Screw System

GUDID 07640177820839

Iliac connector - 70 mm

Neo Medical SA

Bone-screw internal spinal fixation system connector
Primary Device ID07640177820839
NIH Device Record Keyc0edfca8-7570-4f98-a69e-2dbabc68ee22
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeo Medical Pedicle Screw System
Version Model NumberCO-00-70-IL
Company DUNS486778843
Company NameNeo Medical SA
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Length70 Millimeter
Length70 Millimeter
Length70 Millimeter
Length70 Millimeter
Length70 Millimeter
Length70 Millimeter
Length70 Millimeter
Length70 Millimeter
Length70 Millimeter
Length70 Millimeter
Length70 Millimeter
Length70 Millimeter
Length70 Millimeter
Length70 Millimeter
Length70 Millimeter
Length70 Millimeter
Length70 Millimeter
Length70 Millimeter
Length70 Millimeter
Length70 Millimeter
Length70 Millimeter
Length70 Millimeter
Length70 Millimeter
Length70 Millimeter
Length70 Millimeter
Length70 Millimeter
Length70 Millimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107640177820839 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKBThoracolumbosacral Pedicle Screw System

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2024-07-22
Device Publish Date2023-01-25

On-Brand Devices [Neo Medical Pedicle Screw System]

07640177820679Pedicle marker inserter
07640177821188Single Use Pedicle marker (2x)
07640177821256Persuader (US Only)
07640177821232Ratchet T-Handle - 1/4", NS
07640177820884Screwdriver Converter - Hudson, NS
07640177820877Screwdriver Converter - AO, NS
07640177820860Screwdriver Handle, NS
07640177820853Ratchet Screwdriver 1/4", NS
07640177820815Ratchet Handle - 1/4", NS
07640177820808Screwdriver Adaptor - 1/4", NS
07640177820785Screwdriver Adaptor - Hudson, NS
07640177820778Ratchet Handle - Hudson, NS
07640177820433Screw driver Kit
076401778204571.5mm K-wire (1x2)
07640177821225Rod kit pre-bent 45 mm (2x)
07640177821218Rod kit pre-bent 35 mm (2x)
07640177821195Pedicle screw kit 2x(Ø5.0 x 30mm)
07640177821072Revision Guide
07640177821058Pedicle screw kit 2x(Ø8.0 x 40mm)
07640177821041Pedicle screw kit 2x(Ø8.0 x 35mm)
07640177821034Pedicle screw kit 2x(Ø7.0 x 30mm)
07640177821027Pedicle screw kit 2x(Ø6.0 x 30mm)
07640177820839Iliac connector - 70 mm
07640177820822Iliac connector - 40 mm
07640177821096Screw Guide Remover

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