CastleLoc Pectus Bar System
L&K BIOMED Co., Ltd. · Orthopedic
Open FDA's page for this record- Third party flag
- N
- City
- Yongin-Si
- Advisory committee description
- Orthopedic
- Address 1
- #101, 201, 202 16-25, Dongbaekjungang-Ro 16 Beon-Gil
- Address 2
- Giheung-Gu,
- Statement or summary
- Summary
- Product code
- HRS
- Zip code
- 17015
- Applicant
- L&K BIOMED Co., Ltd.
- Decision date
- 2025-02-27
- Decision code
- SESE
- Country code
- KR
- Device name
- CastleLoc Pectus Bar System
- Advisory committee
- OR
- Contact
- Kihyang Kim
- K number
- K243357
- Date received
- 2024-10-29
- Review advisory committee
- OR
- Postal code
- 17015
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- Plate, Fixation, Bone
- Medical specialty description
- Orthopedic
- Regulation number
- 888.3030
- Device class
- 2
- Registration number
- 3011580264, 1226544, 3023265483, 9614438, 3007051929, 3006801265, 3010047402, 3007993775, 3013280419, 3038503572, 3014527928, 3019923333, 1058084, 3010400367, 9615766, 3010470577, 2032830, 3004187715, 3022777867, 3021336182, 2031009, 3015869121, 3011230048, 3043543260, 3011295718, 3026576110, 3010375065, 3010646402, 2531477, 3036756245, 3034676720, 1218017, 3010039400, 3013540005, 3011127597, 1828288, 1038671, 3005751028, 3027242374, 3009756327 +481 more
- FEI number
- 3011580264, 3023265483, 3007051929, 3006801265, 3010047402, 3007993775, 1000139987, 1000069183, 3013280419, 3038503572, 3007282753, 3014527928, 3019923333, 3002807231, 3002808264, 1000143502, 3003690049, 3010400367, 3010470577, 3004187715, 3022777867, 3008782585, 3021336182, 3015869121, 3011230048, 3043543260, 3011295718, 3026576110, 3010375065, 3010646402, 3002821504, 3036756245, 3034676720, 1218017, 3010039400, 3013540005, 3011127597, 1828288, 1038671, 3005751028 +481 more