FDA.reportPublic FDA data

VEGA Cervical Screw System

Primary DI
08800322709993
Brand
VEGA Cervical Screw System
Company
GS Medical Co., Ltd.
Model
GS128-1600
Catalog number
GS128-1600
Device description
Cervical Rod Cutter
Published
2026-09-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NKGPosterior Cervical Screw System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NKGPosterior Cervical Screw SystemOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800322709993PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800322709993088003227099938800322709993

GMDN Terms#

Term, Definition table
TermDefinition
Spinal bone screw, non-bioabsorbableA small, threaded, implantable rod with a screw head and drive intended for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (e.g., surgical steel, titanium alloy, carbon fibre). It is available in various types (e.g., pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used to provide immobilization and stabilization of spinal segments in the treatment of spinal instabilities or deformities. A screw head adaptor intended to stabilize a rod may be included with the screw.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+82432377393udimail@gsmedi.com

Regulatory Flags#

DUNS number
688385418
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800322709924VEGA Cervical Screw SystemGTI0108-0003GTI0108-00032026-09-22
08800322719015VEGA Cervical Screw SystemGS128-0700GS128-07002026-09-22
08800322719022VEGA Cervical Screw SystemGS128-1730GS128-17302026-09-22
08800322759639VEGA Cervical Screw SystemGS128-1010GS128-10102026-09-22
08800322759646VEGA Cervical Screw SystemGS128-1011GS128-10112026-09-22
08800322759653VEGA Cervical Screw SystemGS128-1012GS128-10122026-09-22
08800322759660VEGA Cervical Screw SystemGS128-1013GS128-10132026-09-22
08800322759677VEGA Cervical Screw SystemGS128-1014GS128-10142026-09-22
08800322759684VEGA Cervical Screw SystemGS128-1560GS128-15602026-09-22
08800322759691VEGA Cervical Screw SystemGS128-9000GS128-90002026-09-22
08800322759707VEGA Cervical Screw SystemGS128-9100GS128-91002026-09-22
08800322759714VEGA Cervical Screw SystemGS128-9110GS128-91102026-09-22
08809885759667VEGA Cervical Screw SystemGS128-9011GS128-90112026-09-22
08809885759674VEGA Cervical Screw SystemGS128-9012GS128-90122026-09-22
08809885759797VEGA Cervical Screw SystemGS128-9015GS128-90152026-09-22
08809974779408VEGA Cervical Screw SystemGS128-0200GS128-02002026-09-22
08809974779415VEGA Cervical Screw SystemGS128-0300GS128-03002026-09-22
08809974779422VEGA Cervical Screw SystemGS128-0310GS128-03102026-09-22
08809974779439VEGA Cervical Screw SystemGS128-0320GS128-03202026-09-22
08809974779446VEGA Cervical Screw SystemGS128-0330GS128-03302026-09-22

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