GSS Pedicle Screw System GS0102-8525-A0

GUDID 08806162175653

The GSS Pedicle Screw System is a top-loading multiple component, posterior spinal fixation system which consists of pedicle screws, rods, locking spacer, and a transverse (cross) linking mechanism. The GSS Pedicle Screw System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The GSS Pedicle Screw System implant components are supplied non-sterile, single use and fabricated from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F136. Various sizes of these implants are available. Specialized instruments are available for the application and removal of the GSS Pedicle Screw System. The GSS Pedicle Screw System is a pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-SI vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

GS Medical Co., Ltd.

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID08806162175653
NIH Device Record Key9b86b3b4-75fb-4638-ab77-7dffcf000b64
Commercial Distribution StatusIn Commercial Distribution
Brand NameGSS Pedicle Screw System
Version Model NumberGS0102-8525-A0
Catalog NumberGS0102-8525-A0
Company DUNS688385418
Company NameGS Medical Co., Ltd.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+82432377393
Emailudimail@gsmedi.com
Phone+82432377393
Emailudimail@gsmedi.com
Phone+82432377393
Emailudimail@gsmedi.com
Phone+82432377393
Emailudimail@gsmedi.com
Phone+82432377393
Emailudimail@gsmedi.com
Phone+82432377393
Emailudimail@gsmedi.com
Phone+82432377393
Emailudimail@gsmedi.com
Phone+82432377393
Emailudimail@gsmedi.com
Phone+82432377393
Emailudimail@gsmedi.com
Phone+82432377393
Emailudimail@gsmedi.com
Phone+82432377393
Emailudimail@gsmedi.com
Phone+82432377393
Emailudimail@gsmedi.com
Phone+82432377393
Emailudimail@gsmedi.com
Phone+82432377393
Emailudimail@gsmedi.com
Phone+82432377393
Emailudimail@gsmedi.com
Phone+82432377393
Emailudimail@gsmedi.com
Phone+82432377393
Emailudimail@gsmedi.com
Phone+82432377393
Emailudimail@gsmedi.com

Device Identifiers

Device Issuing AgencyDevice ID
GS108806162175653 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MNIOrthosis, Spinal Pedicle Fixation

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08806162175653]

Moist Heat or Steam Sterilization

[08806162175653]

Moist Heat or Steam Sterilization

[08806162175653]

Moist Heat or Steam Sterilization

[08806162175653]

Moist Heat or Steam Sterilization

[08806162175653]

Moist Heat or Steam Sterilization

[08806162175653]

Moist Heat or Steam Sterilization

[08806162175653]

Moist Heat or Steam Sterilization

[08806162175653]

Moist Heat or Steam Sterilization

[08806162175653]

Moist Heat or Steam Sterilization

[08806162175653]

Moist Heat or Steam Sterilization

[08806162175653]

Moist Heat or Steam Sterilization

[08806162175653]

Moist Heat or Steam Sterilization

[08806162175653]

Moist Heat or Steam Sterilization

[08806162175653]

Moist Heat or Steam Sterilization

[08806162175653]

Moist Heat or Steam Sterilization

[08806162175653]

Moist Heat or Steam Sterilization

[08806162175653]

Moist Heat or Steam Sterilization

[08806162175653]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-08-03
Device Publish Date2023-07-26

On-Brand Devices [GSS Pedicle Screw System]

08806378329758"The GSS Pedicle Screw System is a top-loading multiple component, posterior spinal fixation sys
08806162175479"The GSS Pedicle Screw System is a top-loading multiple component, posterior spinal fixation sys
08806162175196"The GSS Pedicle Screw System is a top-loading multiple component, posterior spinal fixation sys
08806162175172"The GSS Pedicle Screw System is a top-loading multiple component, posterior spinal fixation sys
08806162175165"The GSS Pedicle Screw System is a top-loading multiple component, posterior spinal fixation sys
08806162175721The GSS Pedicle Screw System is a top-loading multiple component, posterior spinal fixation syst
08806162175714The GSS Pedicle Screw System is a top-loading multiple component, posterior spinal fixation syst
08806162175707The GSS Pedicle Screw System is a top-loading multiple component, posterior spinal fixation syst
08806162175691The GSS Pedicle Screw System is a top-loading multiple component, posterior spinal fixation syst
08806162175684The GSS Pedicle Screw System is a top-loading multiple component, posterior spinal fixation syst
08806162175677The GSS Pedicle Screw System is a top-loading multiple component, posterior spinal fixation syst
08806162175660The GSS Pedicle Screw System is a top-loading multiple component, posterior spinal fixation syst
08806162175653The GSS Pedicle Screw System is a top-loading multiple component, posterior spinal fixation syst
08806162175646The GSS Pedicle Screw System is a top-loading multiple component, posterior spinal fixation syst
08806162175455The GSS Pedicle Screw System is a top-loading multiple component, posterior spinal fixation syst
08806162175448The GSS Pedicle Screw System is a top-loading multiple component, posterior spinal fixation syst
08806162175431The GSS Pedicle Screw System is a top-loading multiple component, posterior spinal fixation syst
08806162175424The GSS Pedicle Screw System is a top-loading multiple component, posterior spinal fixation syst
08806162175417The GSS Pedicle Screw System is a top-loading multiple component, posterior spinal fixation syst
08806162175400The GSS Pedicle Screw System is a top-loading multiple component, posterior spinal fixation syst
08806162175394The GSS Pedicle Screw System is a top-loading multiple component, posterior spinal fixation syst
08806162175387The GSS Pedicle Screw System is a top-loading multiple component, posterior spinal fixation syst
08806162175370The GSS Pedicle Screw System is a top-loading multiple component, posterior spinal fixation syst
08806162175189The GSS Pedicle Screw System is a top-loading multiple component, posterior spinal fixation syst
08806162175158The GSS Pedicle Screw System is a top-loading multiple component, posterior spinal fixation syst
08806162175141The GSS Pedicle Screw System is a top-loading multiple component, posterior spinal fixation syst
08806162175134The GSS Pedicle Screw System is a top-loading multiple component, posterior spinal fixation syst
08806162175127The GSS Pedicle Screw System is a top-loading multiple component, posterior spinal fixation syst
08806162175110The GSS Pedicle Screw System is a top-loading multiple component, posterior spinal fixation syst
08806162175004The GSS Pedicle Screw System is a top-loading multiple component, posterior spinal fixation syst
08806162174991The GSS Pedicle Screw System is a top-loading multiple component, posterior spinal fixation syst
08806162174984The GSS Pedicle Screw System is a top-loading multiple component, posterior spinal fixation syst
08806162174977The GSS Pedicle Screw System is a top-loading multiple component, posterior spinal fixation syst
08806162174960The GSS Pedicle Screw System is a top-loading multiple component, posterior spinal fixation syst
08806162174953The GSS Pedicle Screw System is a top-loading multiple component, posterior spinal fixation syst
08806162174946The GSS Pedicle Screw System is a top-loading multiple component, posterior spinal fixation syst
08806162174939The GSS Pedicle Screw System is a top-loading multiple component, posterior spinal fixation syst
08806162174922The GSS Pedicle Screw System is a top-loading multiple component, posterior spinal fixation syst
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