Device Classification Name |
Intervertebral Fusion Device With Bone Graft, Cervical
More FDA Info for this Device |
510(K) Number |
K212266 |
Device Name |
Intervertebral Fusion Device With Bone Graft, Cervical |
Applicant |
Jeil Medical Corporation
702, 703, 704, 705, 706, 804, 805, 807, 812, 815-ho,
55, Digital-ro 34-gil, Guro-gu
Seoul 08378 KR
Other 510(k) Applications for this Company
|
Contact |
Dajung Lee
Other 510(k) Applications for this Contact |
Regulation Number |
888.3080
More FDA Info for this Regulation Number |
Classification Product Code |
ODP
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
07/20/2021 |
Decision Date |
12/21/2021 |
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 |
|