510(k) clearances

The VEGA Cervical Screw System

GS Medical Co., Ltd. · Orthopedic

K254260Substantially EquivalentTraditionalNKG
Open FDA's page for this record
Third party flag
N
City
Cheongju
Advisory committee description
Orthopedic
Address 1
90, Osongsaengmyeong 4-Ro, Osong-Eup
Address 2
Heungdeok-Gu
Statement or summary
Summary
Product code
NKG
Zip code
28161
Applicant
GS Medical Co., Ltd.
Decision date
2026-09-17
Decision code
SESE
Country code
KR
Device name
The VEGA Cervical Screw System
Advisory committee
OR
Contact
Sun Ju Choi
K number
K254260
Date received
2025-12-29
Review advisory committee
OR
Postal code
28161
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Posterior Cervical Screw System
Medical specialty description
Orthopedic
Regulation number
888.3075
Device class
2
Registration number
1835251, 3009169872, 3004209178, 3009380063, 3007922509, 9617544, 3012120772, 3010047454, 1000432246, 3006378738, 3010057495, 3012447612, 2648623, 1835831, 3004635447, 3004774118, 1030489, 3006984710, 3004638600, 3008285983, 3037407500, 3010120326, 1833920, 3007344102, 3008110533, 3009144915, 3006128100, 1526439, 2032098, 3009998573, 2031966, 9615128, 3009941480, 3013491327, 3016438694, 3003387384, 3009887475, 3006783837, 3012711663, 1000517406 +133 more
FEI number
3002980729, 3002806315, 1000514086, 3009169872, 3009380063, 3007922509, 3012120772, 3010047454, 3000215205, 1000432246, 3006378738, 3010057495, 3012447612, 2648623, 3008820440, 3004635447, 3006984710, 3004638600, 3008285983, 3037407500, 3004369318, 3010120326, 3002807113, 3007344102, 3008110533, 3009144915, 3006128100, 1526439, 3009998573, 3001236277, 3009941480, 3013491327, 3016438694, 3003387384, 3002807328, 3009887475, 1000477302, 3003110073, 3012711663, 3002807421 +133 more
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.