FDA Registration Active 🇰🇷 South Korea

SO-35L-SO-L45-TA

Reg #: 3004049923 · FEI: 3004049923 · Expires 2025
Products
2
Proprietary Names
194
Establishment Types
1
Classifications
2

Registration Details

Registration Name
JEIL MEDICAL CORPORATION
Registration Number
3004049923
FEI Number
3004049923
Status
Active
Expiry Year
2025
Initial Importer
No
Address
702,703,704,705,706,707,804,805,807,812,815-ho, 55, Digital-ro 34-gil, Guro-gu,
City
Seoul
Country
KR

Regulatory Submissions

510(k) Number
K171285

Owner / Operator

Firm Name
JEIL MEDICAL CORPORATION
Operator Number
9053245
Address
702,703,704,705,706,707,804,805,807,812,815-ho, 55, Digital-ro 34-gil, Guro-gu
City
Seoul
State
KR-NOTA
Postal Code
08378
Country
KR
Correspondent
Jinwoo Kim

US Agent

Business Name
LK Consulting Group USA, Inc.
Contact Name
Priscilla Chung
Address
18881 Von Karman Ave STE 160
City
Irvine
State
CA
ZIP
92612
Country
US
Phone
714 2025789

Products

Device Name Product Code
Screw, Fixation, Bone HWC
Plate, Fixation, Bone HRS

Proprietary Names

SO-35L-SO-L45-TA SO-35L-SO-L12-T SO-35L-SO-L16-T SO-35L-SO-L10-T SO-35L-SO-L14-T SO-35L-SO-L24-T ARIX Diaphysis System SUMMA Hook Fibula System VD1170 SO-35V-DIST-306 VC3512-L VC3524 SO-35V-DIST-308 SO-35V-DIST-110 VC3516-L VD1020 SO-35L-SO-L22-TA VERUM Diaphysis System Bone Plate VD1210 SO-35-SO-L12-T SO-35-SO-L10-T VC3522-L SO-35-DIST-212 VC3520-L SO-35-SO-L16-T SO-35-DIST-206 SO-35L-SO-L10-TA SO-35-SO-L22-T VD1140 SO-35V-DIST-106 SO-35L-SO-L12-TA SO-35-SO-L24-T VC3510 SO-35L-SO-L14-TA SO-35V-DIST-304 VD1150 VERUM System Bone Screw VD1220 Summa Orthopaedics Diaphysis System Bone Plate SUMMA Diaphysis System SO-35-SO-L14-T SO-35V-DIST-312 SO-35-DIST-209 SO-35V-DIST-108 VD1080 VD1260 VERUM Ankle Fibula Hook System SO-35V-DIST-307 VC3524-L VC3516 VD1110 VD1160 VC3514-L VD1010 SO-35V-DIST-310 SO-35V-DIST-114 SO-35-DIST-211 VD1040 VD1060 VD1240 VC3520 VD1130 PRO-10228 PRO-10307 Summa Orthopaedics System Bone Screw PRO-10309 SO-35L-SO-L20-TA Prometheus System Bone Screw VD1070 VD1250 VERUM Diaphysis System SO-35L-SO-L16-TA SO-35V-DIST-305 SO-35V-DIST-309 SO-35V-DIST-112 SO-35-SO-L18-T SO-35-DIST-207 VC3510-L VC3522 SO-35L-SO-L24-TA VC3512 VD1030 SO-35-SO-L20-T SO-35-DIST-208 VC3518-L SO-35-DIST-210 PRO-10215 VC3514 VD1090 VC3518 VD1120 SO-35V-DIST-311 SO-35V-DIST-116 VD1050 VD1230 PRO-10223 PRO-10214 PRO-10298 SO-35L-SO-L18-TA PRO-10213 PRO-10297 PRO-10211 PRO-10295 PRO-10226 PRO-10305 PRO-10216 PRO-10224 PRO-10300 PRO-10225 PRO-10299 PRO-10303 IN35-SO-L24-T IN35-SO-L65-T PRO-10222 PRO-10229 PRO-10308 PRO-10311 PRO-10314 PRO-10227 PRO-10306 PRO-10310 PRO-10313 Prometheus Diaphysis System Bone Plate PRO-10212 PRO-10296 PRO-10210 IN35-SO-L52-T IN35-SO-L56-T IN35L-SO-L12-TA IN35L-SO-L20-TA IN35L-SO-L24-TA PRO-10302 PRO-10316 IN35-SO-L20-T PRO-10301 PRO-10315 PRO-10312 PRO-10304 IN35L-SO-L50-TA IN35-SO-L46-T PRO-10209 IN35-SO-L32-T IN35-SO-L26-T IN35-SO-L44-T IN35-SO-L10-T IN35-SO-L40-T IN35L-SO-L28-TA IN35L-SO-L18-TA IN35L-SO-L22-TA IN35L-SO-L10-TA IN35L-SO-L14-TA IN35-SO-L28-T IN35L-SO-L34-TA IN35L-SO-L42-TA IN35L-SO-L60-TA IN35-SO-L12-T IN35L-SO-L38-TA IN35L-SO-L45-TA IN35L-SO-L48-TA IN35-SO-L14-T IN35-SO-L50-T IN35L-SO-L26-TA IN35L-SO-L30-TA IN35-SO-L42-T IN35L-SO-L56-TA INLET System Bone Screw IN35L-SO-L40-TA IN35L-SO-L46-TA IN35-SO-L34-T IN35L-SO-L32-TA IN35L-SO-L36-TA IN35L-SO-L44-TA IN35-SO-L38-T IN35L-SO-L52-TA IN35-SO-L45-T IN35-SO-L60-T IN35-SO-L22-T IN35-SO-L70-T IN35-SO-L30-T IN35-SO-L16-T IN35-SO-L36-T IN35-SO-L18-T IN35-SO-L55-T IN35L-SO-L16-TA IN35-SO-L48-T SO-35-SO-L70-T SO-35-SO-L65-T SO-35-SO-L60-T SO-35-SO-L50-T SO-35-SO-L55-T SO-35L-SO-L18-T SO-35L-SO-L22-T SO-35L-SO-L20-T SO-35-SO-L45-T

Establishment Types

Manufacture Medical Device