VEGA Cervical Screw System

Primary DI
08800322693247
Brand
VEGA Cervical Screw System
Company
GS Medical Co., Ltd.
Model
0866-1065
Catalog number
0866-1065
Device description
A 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.
Published
2026-09-30
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K254260000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K254260000The VEGA Cervical Screw SystemGS Medical Co., Ltd.2026-09-17NKG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800322693247PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800322693247088003226932478800322693247

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system rodAn implantable component of a bone-screw internal spinal fixation system in the form of a thin cylinder intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, and also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. This component is designed as a longitudinal (intervertebral) connecting element passing through the system’s implantable screw heads or hooks. It is available in various forms (e.g., straight, curved, rigid, flexible, with varying diameters); flexible types may allow small movements of the spine.

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
false
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
08800322693100VEGA Cervical Screw System0866-10300866-10302026-09-30
08800322693117VEGA Cervical Screw System0866-1030-M00866-1030-M02026-09-30
08800322693124VEGA Cervical Screw System0866-10350866-10352026-09-30
08800322693131VEGA Cervical Screw System0866-1035-M00866-1035-M02026-09-30
08800322693148VEGA Cervical Screw System0866-10400866-10402026-09-30
08800322693155VEGA Cervical Screw System0866-1040-M00866-1040-M02026-09-30
08800322693162VEGA Cervical Screw System0866-10450866-10452026-09-30
08800322693179VEGA Cervical Screw System0866-1045-M00866-1045-M02026-09-30
08800322693186VEGA Cervical Screw System0866-10500866-10502026-09-30
08800322693193VEGA Cervical Screw System0866-1050-M00866-1050-M02026-09-30
08800322693209VEGA Cervical Screw System0866-10550866-10552026-09-30
08800322693216VEGA Cervical Screw System0866-1055-M00866-1055-M02026-09-30
08800322693223VEGA Cervical Screw System0866-10600866-10602026-09-30
08800322693230VEGA Cervical Screw System0866-1060-M00866-1060-M02026-09-30
08800322693254VEGA Cervical Screw System0866-1065-M00866-1065-M02026-09-30
08800322693261VEGA Cervical Screw System0866-10700866-10702026-09-30
08800322693278VEGA Cervical Screw System0866-1070-M00866-1070-M02026-09-30
08800322693285VEGA Cervical Screw System0866-10750866-10752026-09-30
08800322693292VEGA Cervical Screw System0866-1075-M00866-1075-M02026-09-30
08800322693308VEGA Cervical Screw System0866-10800866-10802026-09-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800322693100VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693117VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693124VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693131VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693148VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693155VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693162VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693179VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693186VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693193VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693209VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693216VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693223VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693230VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693254VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693261VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693278VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693285VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693292VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693308VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693315VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693322VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693339VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693346VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693353VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693360VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693377VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693384VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693391VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693407VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30