FDA Registration
Active
🇰🇷 South Korea
112-074, Tray
Reg #: 3004049923
·
FEI: 3004049923
·
Expires 2025
Products
1
Proprietary Names
486
Establishment Types
1
Classifications
1
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
- K192417
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
- [email protected]
- Phone
- 714 2025789
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2019-11-28 |
Proprietary Names
112-074, Tray
ARIX Cannulated Screw System
SO-40-CO-020-T
SO-40-CO-058-T
PRO-10017
PRO-10091
PRO-10145
PRO-90032
PRO-10684
PRO-10197
SO-40-CO-028-T
SO-40-CO-046-T
PRO-10041
PRO-90031
PRO-10114
PRO-10129
PRO-10157
PRO-10180
PRO-10003
PRO-10043
PRO-10063
PRO-10077
PRO-10131
PRO-10159
PRO-10182
SO-40-CO-062-T
111-069-6, Washer
SO-40-CO-038-T
SO-40-CO-034-T
SO-40-CO-070-T
PRO-10018
PRO-10092
PRO-10106
PRO-10146
PRO-10671
PRO-10685
PRO-90027
SO-111-069-2
CC0230
SO-40-CO-054-T
PRO-10032
PRO-10046
PRO-10060
PRO-10066
PRO-10105
PRO-10120
PRO-10148
PRO-10171
PRO-10021
PRO-10036
PRO-10031
PRO-10045
PRO-10059
PRO-10104
PRO-10119
PRO-10147
PRO-10683
PRO-10170
PRO-10011
PRO-10025
PRO-10054
PRO-10085
PRO-10099
PRO-10678
PRO-10205
PRO-10095
PRO-10109
PRO-10029
PRO-10057
PRO-10102
PRO-10117
PRO-10681
PRO-10168
PRO-10039
PRO-10112
PRO-10127
PRO-10178
PRO-10019
PRO-10034
PRO-10093
PRO-10107
PRO-10672
PRO-10686
PRO-90028
PRO-10014
PRO-10001
PRO-10074
PRO-10088
PRO-10015
PRO-10075
PRO-10142
PRO-10156
PRO-10089
PRO-10143
PRO-10195
PRO-10022
PRO-10037
PRO-10194
PRO-10110
PRO-10048
PRO-10068
PRO-10122
PRO-10150
PRO-10173
PRO-10187
112-076, Tray
PRO-10038
PRO-10111
PRO-10177
111-069-1, Washer
SO-40-CO-026-T
SO-112-40-701
SO-40-CO-066-T
111-069-4, Washer
910.14AS01, Tray
SO-40-CO-030-T
111-069-2, Washer
SO-112-120
112-120, Tray
SO-40-CO-024-T
CC0240
111-069-3, Washer
SO-111-069-6
PRO-10033
PRO-10047
PRO-10067
PRO-10121
PRO-10149
PRO-10172
PRO-10051
SO-40-CO-042-T
PRO-10071
PRO-10125
PRO-10139
PRO-10153
PRO-10176
PRO-10191
IN23-CS-026L
IN30-CH-024
IN30-CH-050L
IN30-CS-024
SO-40-CO-050-T
IN40-CO-020-T
PRO-10020
PRO-10035
PRO-10094
PRO-10108
PRO-10673
PRO-90151
PRO-10042
PRO-10062
PRO-10076
PRO-10115
PRO-10130
PRO-10158
PRO-10181
SO-40-CO-022-T
SO-111-069-1
PRO-10009
PRO-10023
PRO-10083
PRO-10097
PRO-10165
PRO-10676
PRO-10203
PRO-10005
PRO-10065
PRO-10079
PRO-10133
PRO-10161
PRO-10184
PRO-10199
PRO-10008
PRO-10082
PRO-10096
PRO-10136
PRO-10164
PRO-10675
PRO-10202
PRO-10002
PRO-10016
PRO-10090
PRO-10144
PRO-10196
PRO-10040
PRO-10113
PRO-10128
PRO-10179
PRO-10013
PRO-10053
PRO-10073
PRO-10087
PRO-10141
PRO-10155
PRO-10193
PRO-10010
PRO-10024
PRO-10084
PRO-10098
PRO-10166
PRO-10677
PRO-10204
PRO-10004
PRO-10064
PRO-10078
PRO-10132
PRO-10160
PRO-10183
PRO-10198
PRO-10007
PRO-10081
PRO-10135
PRO-10163
PRO-10674
PRO-10186
PRO-10201
IN23-CH-023
IN30-CH-030L
IN30-CS-017
IN30-CS-030L
IN60-CS-060L
IN60-CS-080
PRO-10030
PRO-10044
PRO-10058
PRO-10103
PRO-10118
PRO-10682
PRO-10169
PRO-10028
PRO-10056
PRO-10101
PRO-10680
PRO-90160
PRO-10207
IN23-CS-012L
IN30-CH-019
PRO-10050
PRO-10070
PRO-10124
PRO-10138
IN40-CO-046-T
PRO-10152
PRO-10175
PRO-10190
IN45-CS-050
IN60-CS-060
IN60-CS-075L
PRO-10049
PRO-10006
PRO-10080
PRO-10134
PRO-10162
PRO-10185
PRO-10200
PRO-10052
PRO-10072
PRO-10069
PRO-10086
PRO-10123
PRO-10126
PRO-10137
PRO-10140
PRO-10151
PRO-10174
PRO-10189
PRO-10154
PRO-10192
Prometheus System Bone Screw
INLET System Surgical Instrument
IN23-CH-026L
IN23-CS-035
IN30-CH-010
IN30-CH-026L
IN30-CS-012
IN30-CS-026L
IN40-CO-022-T
IN45-CS-028
IN45-CS-042
IN45-CS-056
IN30-CH-016L
IN23-CH-019
IN23-CS-035L
PRO-10012
PRO-10027
PRO-10055
PRO-10100
PRO-10679
PRO-10206
IN30-CH-011
IN30-CH-027
IN30-CS-013
IN30-CS-027
IN30-CS-045L
IN40-CO-028-T
IN23-CH-016
IN23-CS-009L
IN30-CH-017L
IN30-CS-032
IN30-CS-050L
IN40-CO-066-T
IN111-096
IN23-CH-019L
IN30-CH-012
IN30-CH-027L
IN30-CS-014
IN30-CS-027L
IN23-CH-011
IN23-CH-020L
IN23-CH-029
IN30-CH-014
IN30-CH-028L
IN30-CS-015
IN30-CS-028L
IN40-CO-062-T
IN45-CS-040
IN60-CS-045L
IN60-CS-065
IN40-CO-038-T
IN45-CS-048
IN60-CS-055L
IN23-CH-015
IN23-CH-035L
IN30-CH-017
IN30-CS-050
IN40-CO-054-T
IN45-CS-038
IN60-CS-045
IN111-069-2
IN23-CH-022L
IN23-CS-026
IN30-CH-023L
IN30-CH-050
IN30-CS-023L
IN45-CS-024
IN45-CS-052
IN23-CH-026
IN23-CS-017L
IN30-CH-034L
IN30-CS-019
IN30-CS-026
IN30-CS-034L
IN23-CH-021
IN30-CH-015
IN30-CH-029
IN30-CS-015L
IN30-CS-029
IN23-CH-012
IN23-CH-030
IN30-CS-022
IN30-CS-040L
IN40-CO-024-T
IN23-CH-013
IN23-CH-030L
IN30-CS-016
IN30-CS-022L
IN30-CS-029L
IN40-CO-030-T
IN112-074
IN45-CS-046
IN60-CS-030
IN60-CS-055
IN23-CS-011L
IN30-CH-018L
IN40-CO-034-T
IN23-CH-022
IN23-CS-024L
IN30-CH-016
IN30-CH-023
IN30-CH-029L
IN30-CH-045L
IN30-CS-023
IN60-CS-070L
IN23-CH-020
IN23-CS-022
IN30-CH-013
IN30-CH-021L
IN30-CH-040
IN23-CH-014
IN23-CH-035
IN30-CH-030
IN30-CS-016L
IN30-CS-030
IN23-CS-022L
IN40-CO-042-T
IN30-CH-022
IN30-CH-040L
IN112-120
IN23-CH-018L
IN23-CS-019L
IN30-CH-020
IN30-CH-036L
IN40-CO-070-T
IN60-CS-080L
IN60-CS-050
IN60-CS-065L
IN111-096-1
IN30-CH-018
IN30-CH-024L
IN40-CO-026-T
IN45-CS-030
IN45-CS-044
IN45-CS-060
IN60-CS-050L
IN112-076
IN23-CH-024L
IN23-CS-028L
IN23-CS-024
IN30-CH-025
IN30-CS-009
IN30-CS-025
IN30-CH-022L
IN30-CH-045
IN30-CS-045
IN30-CS-021L
IN30-CS-040
IN45-CS-032
IN45-CS-026
IN45-CS-054
IN23-CS-013L
IN30-CH-019L
IN23-CH-018
IN23-CS-018L
IN30-CS-019L
IN23-CS-030L
IN30-CS-036
IN23-CH-024
IN23-CS-014L
IN23-CS-028
IN30-CH-026
IN30-CH-036
IN30-CS-011
IN30-CH-032
IN30-CS-008
IN30-CS-017L
IN30-CS-024L
IN40-CO-058-T
IN23-CH-009
IN23-CH-028
IN23-CH-016L
IN23-CS-010L
IN23-CS-015L
IN23-CS-020L
IN23-CH-010
IN23-CH-028L
IN30-CS-020L
IN30-CS-038
IN30-CH-021
IN30-CH-032L
IN30-CH-028
IN30-CS-014L
IN30-CS-018
IN30-CS-028
IN30-CS-032L
INLET System Bone Screw
IN30-CH-038L
IN30-CS-021
IN45-CS-020
IN45-CS-034
IN60-CS-035
IN60-CS-070
IN30-CS-038L
IN910.14AS01
IN40-CO-050-T
IN111-069-1
IN60-CS-075
IN23-CH-017
IN23-CH-025
IN23-CS-016L
IN23-CH-027
IN30-CH-034
IN30-CS-018L
IN30-CS-034
IN45-CS-022
IN30-CS-020
IN30-CS-036L
IN23-CS-020
IN30-CH-020L
IN30-CH-038
IN23-CH-017L
IN23-CS-030
IN30-CH-025L
IN30-CS-010
IN30-CS-025L
IN45-CS-036
IN60-CS-040
Establishment Types
Manufacture Medical Device