FDA Registration Active 🇰🇷 South Korea

SO-35L-SO-L20-T

Reg #: 3014937101 · FEI: 3014937101 · Expires 2025
Products
2
Proprietary Names
474
Establishment Types
1
Classifications
2

Registration Details

Registration Name
JEIL MEDICAL CORPORATION
Registration Number
3014937101
FEI Number
3014937101
Status
Active
Expiry Year
2025
Initial Importer
No
Address
380, Beoman-ro
City
Siheung-si Gyeonggi
Country
KR

Regulatory Submissions

510(k) Number
K201656

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-L20-T SO-28L-SO-S24-T SO-35-SO-L45-T SO-35L-SO-L16-T SO-28L-SO-S20-T SO-28-SO-S48-TA SO-28-SO-S70-TA SO-28L-SO-L24-TA SO-35L-SO-L45-TA SO-28L-SO-S60-TA SO-35L-SO-L24-T SO-28L-SO-S10-T SO-28L-SO-S70-TA SO-28-SO-S55-TA SO-28L-SO-S12-T 112-136-1 112-136-2 112-136-3 ARIX Elbow System SO-35-SO-L36-T SO-20L-SO-030-TA SO-25L-SO-030-TA SO-28-SO-S10-TA SO-25-PLUL-106 SO-35-PLUL-105-R SO-25L-SO-010-TA SO-25-SO-018-TA SO-25L-SO-048-TA SO-28L-SO-S08-TA SO-28-SO-S44-TA SO-35-DPHU-106-R SO-28L-SO-S20-TA SO-25L-SO-014-TA SO-25-SO-022-TA SO-28L-SO-S22-TA SO-35-SO-L52-T SO-35L-SO-L34-TA SO-35-SO-L38-T IN35-DLHU-107-L SO-20-SO-008-TA SO-25L-SO-032-TA SO-25-PLUL-107 SO-35-DMHU-201-L IN20-SO-026-TA IN25L-SO-016-TA IN25L-SO-046-TA IN25-SO-042-TA IN28L-SO-S24-TA IN28-SO-S38-TA SO-35-SO-L44-T SO-25L-SO-038-TA SO-35-DMHU-206-L IN35-SO-L26-T SO-35-SO-L24-T SO-20-SO-022-TA SO-28-SO-S36-TA SO-35-PLUL-005-R SO-112-136 SO-35L-SO-L50-TA SO-25L-SO-020-TA SO-25-SO-034-TA SO-35-DLHU-103-R SO-35L-SO-L12-TA SO-25L-SO-018-TA SO-25L-SO-028-TA SO-25-SO-032-TA SO-35-DLHU-102-R SO-25L-SO-044-TA SO-25-SO-048-TA SO-35-DMHU-204-R SO-35-DPHU-103-R SO-20-SO-028-TA SO-25-SO-028-TA SO-35-PLUL-104-L SO-35-DLHU-105-L SO-35-SO-L40-T SO-20-SO-010-TA SO-25L-SO-034-TA SO-25-PLUL-109 SO-35-DMHU-202-L IN25-PLUL-005 112-136 IN20L-SO-022-TA IN20-SO-012-TA IN25L-SO-030-TA IN35-SO-L12-T SO-28L-SO-S14-TA SO-35-SO-L30-T SO-25-SO-016-TA SO-20L-SO-024-TA SO-28L-SO-S44-TA SO-25-PLUL-007 SO-112-136-3 SO-35L-SO-L28-TA SO-35L-SO-L60-TA IN35-PLUL-007-R IN20L-SO-020-TA IN25L-SO-022-TA IN25-SO-010-TA IN28-SO-S18-TA IN35L-SO-L34-TA IN35L-SO-L38-TA IN35L-SO-L42-TA IN35L-SO-L45-TA IN35-SO-L50-T IN35-SO-L55-T SO-28L-SO-S16-TA SO-35-SO-L32-T SO-20L-SO-026-TA SO-28L-SO-S46-TA SO-25-PLUL-009 SO-35L-SO-L30-TA SO-35-SO-L56-T SO-28-SO-S12-TA SO-25L-SO-024-TA SO-25-SO-038-TA SO-28L-SO-S32-TA SO-35-DLHU-107-R SO-35L-SO-L16-TA SO-25L-SO-040-TA SO-35-DMHU-201-R SO-35-DPHU-106-L SO-25L-SO-042-TA SO-25-SO-046-TA SO-35-DMHU-202-R SO-35-DPHU-108-L IN35-DLHU-107-R IN35-DPHU-106-R IN35-DLHU-102-L IN35-DMHU-206-L IN20-SO-020-TA IN25L-SO-042-TA IN28L-SO-S20-TA IN28-SO-S08-TA IN28-SO-S34-TA IN35-DMHU-202-L IN35-PLUL-004-L IN20-SO-030-TA IN25L-SO-018-TA IN35-SO-L28-T IN35-DPHU-106-L IN35-PLUL-105-L IN28L-SO-L12-TA IN28-SO-S12-TA SO-28-SO-S18-TA SO-25-SO-010-TA SO-20L-SO-018-TA SO-25-SO-044-TA SO-28L-SO-S38-TA SO-20-PLRA-310 SO-35L-SO-L22-TA SO-25L-SO-022-TA SO-25-SO-036-TA SO-35-DLHU-105-R SO-35L-SO-L14-TA SO-28L-SO-S18-TA SO-25L-SO-012-TA SO-25-SO-020-TA SO-28L-SO-S10-TA SO-28-SO-S46-TA SO-35-DPHU-108-R SO-35L-SO-L32-TA IN35-PLUL-005-R IN20L-SO-018-TA IN35-DPHU-104-R IN35-PLUL-104-R IN20L-SO-010-TA IN25L-SO-024-TA IN35L-SO-L16-TA IN35L-SO-L20-TA SO-35-SO-L42-T IN35-SO-L18-T SO-35-SO-L12-T SO-20-SO-012-TA SO-25L-SO-036-TA SO-35-DMHU-204-L SO-25-SO-026-TA SO-28L-SO-S26-TA SO-28-SO-S24-TA SO-35L-SO-L10-TA SO-35L-SO-L38-TA SO-25L-SO-008-TA SO-25L-SO-046-TA SO-25-SO-050-TA SO-28-SO-S42-TA SO-35-DMHU-206-R SO-35-DPHU-104-R IN35-DPHU-103-R IN35-PLUL-008-R IN20L-SO-008-TA IN25L-SO-044-TA IN28-SO-S10-TA IN35L-SO-L52-TA IN35-SO-L42-T SO-35-SO-L20-T SO-35-SO-L48-T SO-20L-SO-014-TA SO-20-SO-018-TA SO-28-SO-S32-TA SO-20-PLRA-210 SO-35-PLUL-008-L SO-35L-SO-L46-TA IN20-PLRA-210 IN35-DLHU-103-R IN25-SO-040-TA IN28L-SO-S22-TA SO-35-SO-L18-T SO-35-SO-L46-T IN28-SO-S36-TA SO-35-SO-L34-T SO-20L-SO-028-TA SO-28-SO-S08-TA SO-25-PLUL-105 SO-35-PLUL-104-R SO-20L-SO-012-TA SO-20-SO-016-TA SO-28-SO-S30-TA SO-20-PLRA-208 SO-35-PLUL-007-L SO-35-SO-L60-T SO-35L-SO-L44-TA SO-35-SO-L10-T SO-25L-SO-016-TA SO-25-SO-024-TA SO-28L-SO-S24-TA SO-28-SO-S22-TA SO-35L-SO-L36-TA SO-28L-SO-S12-TA SO-35-SO-L28-T SO-25-SO-014-TA SO-20L-SO-022-TA SO-28L-SO-S42-TA SO-25-PLUL-006 SO-112-136-2 SO-35L-SO-L26-TA SO-35L-SO-L56-TA SO-20-SO-030-TA SO-25-SO-030-TA SO-35-PLUL-105-L SO-35-DLHU-107-L SO-20-SO-026-TA SO-25L-SO-050-TA SO-28-SO-S40-TA SO-35-PLUL-008-R SO-35-DLHU-103-L SO-35-SO-L16-T SO-20L-SO-010-TA SO-20-SO-014-TA SO-28L-SO-S30-TA SO-28-SO-S28-TA SO-20-PLRA-109 SO-35-PLUL-005-L SO-35-SO-L14-T IN20-PLRA-308 IN35-DLHU-105-L IN20-SO-010-TA IN20-SO-024-TA IN25L-SO-008-TA IN25L-SO-036-TA SO-20L-SO-008-TA SO-28L-SO-S28-TA SO-28-SO-S26-TA SO-35-SO-L22-T SO-35-SO-L50-T SO-20-PLRA-107 SO-20L-SO-016-TA SO-20-SO-020-TA SO-35-PLUL-004-L SO-28-SO-S34-TA SO-35-PLUL-004-R SO-35L-SO-L48-TA SO-35L-SO-L40-TA IN35L-SO-L48-TA IN35-SO-L22-T SO-35L-SO-L42-TA IN35-SO-L60-T IN28L-SO-L14-TA SO-28-SO-S14-TA IN35L-SO-L36-TA IN35L-SO-L44-TA IN35-SO-L30-T IN35-SO-L52-T SO-25L-SO-026-TA SO-25-SO-040-TA SO-28L-SO-S34-TA SO-35-DPHU-103-L SO-35L-SO-L18-TA IN35-DMHU-201-L IN35-DPHU-108-L IN20-SO-028-TA IN25L-SO-038-TA IN28L-SO-S44-TA IN35L-SO-L28-TA SO-28-SO-S20-TA IN35L-SO-L32-TA SO-35-SO-L26-T IN35L-SO-L40-TA IN35-PLUL-004-R IN20L-SO-016-TA SO-25-SO-012-TA SO-20L-SO-020-TA SO-28L-SO-S40-TA SO-25-PLUL-005 SO-35L-SO-L24-TA SO-35L-SO-L52-TA IN25L-SO-020-TA IN28L-SO-S46-TA IN35-PLUL-005-L IN25L-SO-050-TA IN25-SO-008-TA IN28L-SO-L18-TA SO-28-SO-S16-TA SO-25-SO-008-TA SO-25-SO-042-TA SO-28L-SO-S36-TA SO-20-PLRA-308 SO-35-DPHU-104-L SO-35L-SO-L20-TA IN28-SO-S16-TA IN35L-SO-L10-TA IN35L-SO-L14-TA IN35L-SO-L18-TA IN20-PLRA-107 IN20L-SO-030-TA IN25L-SO-034-TA IN25-SO-038-TA IN35-SO-L14-T SO-20-SO-024-TA SO-28-SO-S38-TA SO-35-PLUL-007-R SO-35-DLHU-102-L SO-112-136-1 IN20-PLRA-310 IN35-PLUL-008-L IN25-SO-032-TA IN28L-SO-L22-TA IN28-SO-S28-TA IN35-SO-L32-T INLET Elbow System Bone Plate IN25-PLUL-007 IN35-PLUL-007-L IN28L-SO-L20-TA IN20L-SO-024-TA IN20-SO-014-TA IN25L-SO-010-TA IN25-SO-022-TA IN25-SO-034-TA IN28L-SO-S16-TA IN28-SO-S30-TA IN35L-SO-L24-TA IN35-SO-L16-T IN35-PLUL-105-R IN20L-SO-012-TA IN20L-SO-026-TA IN28L-SO-S08-TA IN28L-SO-S34-TA IN28-SO-S22-TA IN35-SO-L48-T IN35-DMHU-201-R IN35-DPHU-108-R IN25L-SO-048-TA IN28L-SO-S26-TA IN28-SO-S40-TA IN35L-SO-L56-TA IN35-SO-L40-T IN25-PLUL-107 IN35-DMHU-204-L IN20-SO-018-TA IN25L-SO-012-TA IN25-PLUL-106 IN35-DMHU-202-R IN25-SO-046-TA IN28L-SO-S28-TA IN28-SO-S42-TA IN35-DLHU-105-R IN25L-SO-040-TA IN25-SO-036-TA IN35-SO-L24-T IN25-SO-020-TA IN28L-SO-S18-TA IN28-SO-S32-TA IN28L-SO-S14-TA IN28L-SO-S42-TA IN35L-SO-L46-TA IN35L-SO-L50-TA IN35-SO-L44-T IN35-SO-L56-T IN35-SO-L65-T IN35L-SO-L12-TA IN35-SO-L45-T IN25-PLUL-006 IN25-SO-012-TA IN28L-SO-L24-TA IN28-SO-S20-TA IN35-DPHU-104-L IN35-PLUL-104-L IN25-SO-050-TA IN25-PLUL-009 IN28L-SO-L10-TA IN28L-SO-S32-TA IN28-SO-S46-TA IN35-SO-L36-T IN20-PLRA-208 IN35-DLHU-103-L IN25-SO-044-TA INLET System Bone Screw IN25-PLUL-109 IN35-DPHU-103-L IN35-DMHU-204-R IN35-SO-L70-T IN20L-SO-014-TA IN20L-SO-028-TA IN20-SO-008-TA IN20-SO-022-TA IN25L-SO-014-TA IN25L-SO-026-TA IN25L-SO-028-TA IN28L-SO-S38-TA IN25-SO-018-TA IN28L-SO-S12-TA IN28-SO-S26-TA IN28-SO-S14-TA IN28L-SO-S40-TA IN35-SO-L46-T IN35-SO-L10-T IN20-PLRA-109 IN35-DLHU-102-R IN25-PLUL-105 IN20-SO-016-TA IN25L-SO-032-TA IN25-SO-014-TA IN35L-SO-L22-TA IN28L-SO-S36-TA IN35L-SO-L26-TA IN35-SO-L38-T IN35-SO-L20-T IN25-SO-016-TA IN28L-SO-L16-TA IN28L-SO-S10-TA IN28-SO-S24-TA SO-35-SO-L70-T IN35-SO-L34-T IN35-DMHU-206-R IN25-SO-048-TA IN28L-SO-S30-TA IN28-SO-S44-TA IN35L-SO-L30-TA IN35L-SO-L60-TA SO-35-SO-L55-T SO-28L-SO-L12-TA SO-35-SO-L65-T SO-28L-SO-L14-TA SO-35L-SO-L18-T SO-28L-SO-S22-T SO-35L-SO-L22-T SO-28L-SO-S26-T SO-28L-SO-S48-TA SO-28L-SO-L10-TA SO-28-SO-S65-TA SO-28L-SO-L22-TA SO-35L-SO-L14-T SO-28L-SO-S18-T SO-28L-SO-S65-TA SO-28-SO-S60-TA SO-28L-SO-L20-TA SO-28L-SO-L16-TA SO-28-SO-S50-TA SO-28L-SO-S55-TA SO-35L-SO-L12-T SO-28L-SO-S16-T SO-28L-SO-S50-TA SO-35L-SO-L10-T SO-28L-SO-S14-T SO-28L-SO-S08-T

Establishment Types

Manufacture Medical Device