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GSS Pedicle Screw System

FDA UDI

Class II (US FDA UDI)

by GS Medical Co., Ltd.

Identity

Trade Name
GSS Pedicle Screw System FDA UDI
Generic Name
Bone-screw internal spinal fixation system, non-sterile FDA UDI
Device Name
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. FDA UDI
Model / Reference
GS0102-7520-A0 FDA UDI
Description
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. FDA UDI

Identifiers

Catalog Number
GS0102-7520-A0 FDA UDI
Primary DI / UDI-DI
08806162175370 FDA UDI
510(k) Number
K053573 FDA UDI
FDA Product Code
MNI FDA UDI
MNH FDA UDI
GMDN Term
Bone-screw internal spinal fixation system, non-sterile FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3070 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Bone-screw internal spinal fixation system, non-sterile

GSS Pedicle Screw System by GS Medical Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bone-screw internal spinal fixation system, non-sterile.

Cleared under the same submission

K053573 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
GS Medical Co., Ltd.

Sources (1)

  • FDA UDI 5007cda0-bc4b-40d8-9254-8b42c7a92851 36 fields · synced May 31, 2026