VEGA Cervical Screw System

Primary DI
08800322693988
Brand
VEGA Cervical Screw System
Company
GS Medical Co., Ltd.
Model
1440-0045
Catalog number
1440-0045
Device description
An 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.
Published
2026-11-03
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
false

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
08800322693988PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800322693988088003226939888800322693988

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
true
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
08800322693902VEGA Cervical Screw System1440-00251440-00252026-11-03
08800322693919VEGA Cervical Screw System1440-0025-M01440-0025-M02026-11-03
08800322693926VEGA Cervical Screw System1440-00301440-00302026-11-03
08800322693933VEGA Cervical Screw System1440-0030-M01440-0030-M02026-11-03
08800322693940VEGA Cervical Screw System1440-00351440-00352026-11-03
08800322693957VEGA Cervical Screw System1440-0035-M01440-0035-M02026-11-03
08800322693964VEGA Cervical Screw System1440-00401440-00402026-11-03
08800322693971VEGA Cervical Screw System1440-0040-M01440-0040-M02026-11-03
08800322693995VEGA Cervical Screw System1440-0045-M01440-0045-M02026-11-03
08800322694008VEGA Cervical Screw System1440-00501440-00502026-11-03
08800322694015VEGA Cervical Screw System1440-0050-M01440-0050-M02026-11-03
08800322694022VEGA Cervical Screw System1440-00551440-00552026-11-03
08800322694039VEGA Cervical Screw System1440-0055-M01440-0055-M02026-11-03
08800322694046VEGA Cervical Screw System1440-00601440-00602026-11-03
08800322694053VEGA Cervical Screw System1440-0060-M01440-0060-M02026-11-03
08800322694060VEGA Cervical Screw System1440-00651440-00652026-11-03
08800322694077VEGA Cervical Screw System1440-0065-M01440-0065-M02026-11-03
08800322694084VEGA Cervical Screw System1440-00701440-00702026-11-03
08800322694091VEGA Cervical Screw System1440-0070-M01440-0070-M02026-11-03
08800322694107VEGA Cervical Screw System1440-00751440-00752026-11-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800322693902VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-11-03
08800322693919VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-11-03
08800322693926VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-11-03
08800322693933VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-11-03
08800322693940VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-11-03
08800322693957VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-11-03
08800322693964VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-11-03
08800322693971VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-11-03
08800322693995VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-11-03
08800322694008VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-11-03
08800322694015VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-11-03
08800322694022VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-11-03
08800322694039VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-11-03
08800322694046VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-11-03
08800322694053VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-11-03
08800322694060VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-11-03
08800322694077VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-11-03
08800322694084VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-11-03
08800322694091VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-11-03
08800322694107VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-11-03
08800322694114VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-11-03
08800322694121VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-11-03
08800322694138VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-11-03
08800322694145VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-11-03
08800322694152VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-11-03
08800322694169VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-11-03
08800322694176VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-11-03
08800322694183VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-11-03
08800322694190VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-11-03
08800322694206VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-11-03