FDA Registration
Active
🇰🇷 South Korea
JD28-3095
Reg #: 3008285983
·
FEI: 3008285983
·
Expires 2025
Products
1
Proprietary Names
488
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- L&K BIOMED CO.,LTD.
- Registration Number
- 3008285983
- FEI Number
- 3008285983
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- #101, 201, #202, 16-25, Dongbaekjungang-ro 16 beon-gil, Giheung-gu
- City
- Yongin-SI Gyeonggi
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K250892
Owner / Operator
- Firm Name
- L&K BIOMED CO., LTD.
- Operator Number
- 10033804
- Address
- #101, 201, 202, 16-25, Dongbaekjungang-ro,, 16 beon-gil, Giheung-gu
- City
- Youngin-si
- State
- Gyeonggi
- Postal Code
- 17015
- Country
- KR
- Correspondent
- Kihyang Kim
US Agent
- Business Name
- ComplianceAcuity, Inc
- Contact Name
- Kevin Randall
- Address
- 485 Clinton St, #888
- City
- Ridgeway
- State
- CO
- ZIP
- 81432
- Country
- US
- [email protected]
- Phone
- 303 8280844
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2025-04-28 |
Proprietary Names
JD28-3095
JD30-2145
LB12-2012
JD30-2125
OB28-9055
OB28-9070
WB28-6100
WB30-5075
OB30-1090
OB30-9195
WB28-5105
JD28-3170
OB28-1120
OB30-1100
WB30-6090
JD30-3125
OB30-0080
WB30-6065
OB28-1160
OB28-1150
WB30-5090
OB28-0175
WB30-6175
BF27-2015
JD30-2110
JD30-3140
WB30-6200
JD30-3130
JD28-3090
OB30-0195
BF27-2515
OB30-9100
WB28-6085
LB12-2018
WB30-5080
JD30-2105
OB30-1195
JD28-2185
OB28-0155
OB30-1055
OB30-1060
OB30-0085
OB28-1060
JD28-3085
JD30-3185
JD28-3115
OB30-1145
OB28-0100
LB12-2019
JD30-2185
JD30-2055
JD30-3150
WB28-5115
JD30-3120
OB30-0075
OB30-0185
WB30-6185
JD30-3105
JD28-3185
LB12-2009
OB30-0100
LB10-2013
WB28-6110
OB28-0165
WB28-5065
OB30-9115
JD30-3095
WB30-5155
JD28-2165
WB30-6070
JD30-2135
OB28-1200
JD30-3100
OB28-0105
LB10-2016
OB28-1125
JD28-2055
OB28-1075
WB28-5130
JD30-2050
OB30-0090
WB28-5190
OB30-9050
OB30-1150
WB30-6115
OB30-9185
WB30-5130
JD30-3160
LB10-2010
WB28-5080
WB28-5195
JD30-2060
CastleLoc Pectus Bar System
WB28-5180
JD30-3080
JD30-2160
OB30-0105
WB28-5200
WB30-5200
JD30-3055
OB30-9110
JD28-2125
JD28-3180
WB30-5060
OB30-1105
BF23-3020
WB30-6130
JD28-2155
OB30-1155
BF23-2015
LB12-2020
JD28-3070
OB28-9195
OB28-9115
OB28-9125
OB28-1085
WB28-5120
JD28-2080
JD30-2100
JD28-2050
WB28-6095
OB28-9160
OB30-9200
OB28-0085
JD30-3110
OB28-9110
WB28-5125
JD28-3190
OB28-9085
WB28-5150
OB28-0160
JD28-2190
OB28-0150
BF27-3015
WB30-5170
BF27-3020
OB28-0125
JD28-3120
JD28-2135
OB30-0165
OB30-0050
JD28-3055
WB30-6060
JD28-3165
WB28-6160
WB30-5105
WB28-6170
OB30-9155
WB28-6150
WB30-6110
WB28-6115
OB30-0055
WB28-6125
OB28-0180
WB28-5140
BF27-3515
OB28-9130
JD30-3145
WB30-5110
OB30-1175
JD30-3090
JD30-3085
WB28-5110
BF23-3515
JD28-3080
OB30-0065
WB30-6190
OB28-0070
OB30-1135
LB10-2009
WB28-6105
OB30-9090
OB28-1195
OB30-0130
JD28-2175
OB28-1170
OB28-0120
OB30-1200
WB28-6090
OB28-0190
OB28-1145
JD28-2090
OB30-0170
OB30-1075
LB10-2011
WB28-5090
OB28-1105
OB30-1165
JD30-2200
LB12-2011
LB12-2014
OB28-9185
OB28-0065
JD28-3060
JD28-3175
JD30-2195
WB30-6150
WB30-5100
JD28-2120
BC05-01409
JD30-2155
JD28-3130
OB28-1155
OB30-0110
OB28-9065
OB30-9180
LB10-2018
OB28-1135
WB28-5135
OB30-1080
OB30-1185
OB30-9135
WB28-6140
WB28-5165
OB28-9200
JD30-3115
OB28-9175
JD30-2150
WB30-6075
WB30-6165
JD30-3050
JD28-3050
OB28-0170
JD30-2175
WB28-5075
JD30-2165
OB28-1070
OB28-1055
WB28-6145
WB28-5145
BC05-6512
WB28-6195
LB10-2019
OB30-0180
WB28-5085
JD28-2130
WB30-6180
WB28-5185
OB30-1110
OB30-0095
JD30-2170
OB28-9050
BC05-1683
OB30-1160
LB12-2007
WB30-6195
JD28-3065
JD28-3100
WB28-6055
OB30-9055
JD30-2120
OB30-0200
OB30-9140
JD30-3135
WB30-6135
OB28-9060
JD30-3190
OB30-9175
JD30-3180
LB10-2017
WB30-5145
WB30-6050
JD30-2090
LB10-2008
WB28-6185
BF23-2520
WB30-5185
OB28-9150
JD28-3140
WB28-6135
OB30-9160
JD30-3075
WB28-6080
WB30-6055
BC05-01209
OB28-1190
OB30-9150
OB30-1170
OB30-0120
BF23-3520
WB28-5155
WB30-5115
OB28-9120
WB28-6190
WB28-5170
OB28-9095
JD30-2070
LB10-2015
JD28-2115
JD30-2065
WB30-6100
OB28-1130
OB30-0145
JD28-3150
OB28-1080
OB28-9145
OB28-0130
OB30-0115
JD28-2150
OB28-0115
LB12-2008
BC05-0175
BF23-2020
WB30-6170
LB10-2007
OB30-0155
OB30-0160
WB28-6200
WB30-5175
JD28-2105
OB28-1175
WB30-5180
WB28-6075
JD30-2085
OB28-0185
OB30-1140
OB30-1085
WB28-6175
OB30-1130
BF23-2515
OB28-1090
OB30-0150
OB30-1070
OB30-9125
WB30-6085
JD28-2170
WB28-5100
OB28-1165
OB28-0075
WB30-5135
OB30-0060
JD30-2075
OB28-1095
OB28-1140
OB30-9085
OB28-9135
JD30-2190
OB30-9095
OB28-1180
JD28-2100
WB30-5150
WB28-5160
WB30-5160
WB30-6120
JD30-3170
LB10-2020
JD28-2085
JD30-3155
OB30-1065
WB30-5070
OB30-0140
OB30-0125
WB28-5055
JD28-3125
JD30-3065
OB30-0070
JD28-3105
BF27-2020
WB30-5120
LB10-2012
JD28-3160
OB28-0200
BC05-01809
WB30-6155
OB28-0140
JD28-2060
OB30-0190
JD28-2160
WB30-6080
JD30-2140
OB28-9075
OB30-9190
WB28-5095
JD28-3200
OB28-1115
WB28-6050
WB28-6165
OB28-0090
OB28-9100
JD30-2095
OB28-9180
JD28-3110
OB28-9105
OB28-9190
WB30-6105
JD30-2130
JD30-3165
OB28-9090
WB28-6155
OB28-0145
OB28-1110
CN03-0007
BF27-2520
WB28-5070
WB28-6120
JD30-3070
JD28-3195
WB28-6130
LB12-2015
BF27-3520
WB28-6065
WB30-5085
OB30-9130
JD28-3145
OB28-9155
OB28-0135
JD30-3195
LB12-2010
OB30-9165
OB28-1050
OB28-0110
OB30-1095
WB28-6180
OB30-9070
JD30-2080
WB30-5125
WB30-6160
OB28-1065
OB30-1180
WB30-6095
WB28-5175
OB30-9170
JD28-2200
JD30-3175
WB30-5195
LB10-2014
OB28-0050
WB30-5140
OB30-9105
WB30-5055
OB28-9140
JD28-2065
OB30-1050
OB28-1100
BC05-0176
JD28-3075
OB30-9060
LB12-2016
OB30-1125
JD28-2075
WB28-6070
OB30-9065
JD28-2110
OB30-9075
JD30-2180
WB30-6125
BC05-01509
WB28-5060
OB28-9165
JD28-2180
OB28-0195
JD28-2095
JD30-2115
OB28-0055
JD30-3200
OB30-9120
WB30-6145
JD28-2070
WB30-5065
WB28-5050
OB28-1185
OB28-0095
WB30-6140
WB30-5165
OB28-0080
LB12-2013
JD30-3060
LB12-2017
OB28-0060
JD28-2140
OB30-1115
WB30-5190
BF23-3015
OB30-0135
OB30-9145
JD28-3135
WB30-5050
OB28-9170
WB30-5095
OB30-0175
JD28-2145
WB28-6060
OB28-9080
OB30-9080
OB30-1120
JD28-3155
JD28-2195
OB30-1190
Establishment Types
Manufacture Medical Device