Neo Pedicle Screw System

GUDID 07640177820563

Rod kit straight 400 mm (2x)

Neo Medical SA

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Primary Device ID07640177820563
NIH Device Record Key9b516e06-40ed-422a-b13c-69918e03cec5
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeo Pedicle Screw System
Version Model NumberRD-04-00-ST
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

Length400 Millimeter
Length400 Millimeter
Length400 Millimeter
Length400 Millimeter
Length400 Millimeter
Length400 Millimeter
Length400 Millimeter
Length400 Millimeter
Length400 Millimeter
Length400 Millimeter
Length400 Millimeter
Length400 Millimeter
Length400 Millimeter
Length400 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

Device Identifiers

Device Issuing AgencyDevice ID
GS107640177820563 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-12-06
Device Publish Date2021-11-26

On-Brand Devices [Neo Pedicle Screw System]

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

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