Device Classification Name |
Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
More FDA Info for this Device |
510(K) Number |
K222229 |
Device Name |
Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease |
Applicant |
CG Bio Co., Ltd.
B1, 1F, 2F, C-dong, 29, Jeyakdanji-ro, Hyangnam-eup
Hwaseong-Si 18608 KR
Other 510(k) Applications for this Company
|
Contact |
Iris Kim
Other 510(k) Applications for this Contact |
Regulation Number |
888.3070
More FDA Info for this Regulation Number |
Classification Product Code |
NKB
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
07/25/2022 |
Decision Date |
05/25/2023 |
Decision |
SESE - SUBST EQUIV |
Classification Advisory Committee |
OR - Orthopedic |
Review Advisory Committee |
OR - Orthopedic |
Statement / Summary / Purged Status |
Summary |
Type |
Traditional |
Reviewed By Third Party |
N |
Expedited Review |
|