FDA.reportPublic FDA data

VEGA Cervical Screw System

Primary DI
08800424704063
Brand
VEGA Cervical Screw System
Company
GS Medical Co., Ltd.
Model
GS128-2000
Catalog number
GS128-2000
Device description
Cervical Tower Reducer
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
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800424704063PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800424704063088004247040638800424704063

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
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
08800322693988VEGA Cervical Screw System1440-00451440-00452026-11-03
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776437855MillenniumAvalign Technologies, Inc.LXH2026-11-04
00190776437862MillenniumAvalign Technologies, Inc.LXH2026-11-04
00190776439873MilleniumAvalign Technologies, Inc.LXH2026-11-04
00810155330057Tigon MedicalTigon Medical LLCLXH2026-11-04
08800308486030INNOVERSE SPINAL SYSTEMCG MedTech Co.,Ltd.LXH2026-11-04
09353903030331OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDLXH2026-11-04
09353903030348OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDLXH2026-11-04
09353903030379OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDLXH2026-11-04
09353903030386OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDLXH2026-11-04
09353903030393OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDLXH2026-11-04
09353903030416OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDLXH2026-11-04
09353903030430OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDLXH2026-11-04
00841731133564REDEMPTION Beaming SystemVILEX LLCLXH2026-11-03
00841731133571REDEMPTION Beaming SystemVILEX LLCLXH2026-11-03
00841731133601REDEMPTION Beaming SystemVILEX LLCLXH2026-11-03
00841731133618REDEMPTION Beaming SystemVILEX LLCLXH2026-11-03
00841731133625REDEMPTION Beaming SystemVILEX LLCLXH2026-11-03
00841731133632REDEMPTION Beaming SystemVILEX LLCLXH2026-11-03
00841731133649REDEMPTION Beaming SystemVILEX LLCLXH2026-11-03
00841731133656REDEMPTION Beaming SystemVILEX LLCLXH2026-11-03
00841731133670REDEMPTION Beaming SystemVILEX LLCLXH2026-11-03
00841731133687REDEMPTION Beaming SystemVILEX LLCLXH2026-11-03
00841731133700REDEMPTION Beaming SystemVILEX LLCLXH2026-11-03
00841731133731REDEMPTION Beaming SystemVILEX LLCLXH2026-11-03
07630699714822Surgical Manual InstrumentMedacta International SALXH2026-11-03
08809974815977Anyplus ll Spinal Fixation SystemGS Medical Co., Ltd.LXH2026-11-03
00810130207596MSIModern Surgical Instruments LLCLXH2026-11-02
07630894822506APTUSMedartis AGLXH2026-11-02
07630894822551APTUSMedartis AGLXH2026-11-02
07630894822568APTUSMedartis AGLXH2026-11-02