FDA 510(k) Application Details - K192417
Device Classification Name |
Screw, Fixation, Bone
More FDA Info for this Device |
510(K) Number |
K192417 |
Device Name |
Screw, Fixation, Bone |
Applicant |
Jeil Medical Corporation
702,703,704,705,706,804,805,807,812,815-ho, 55,
Digital-ro 34-gil, Guro-gu
Seoul 38378 KR
Other 510(k) Applications for this Company
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Contact |
Sejin Ryu
Other 510(k) Applications for this Contact |
Regulation Number |
888.3040
More FDA Info for this Regulation Number |
Classification Product Code |
HWC
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
09/04/2019 |
Decision Date |
11/26/2019 |
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 |
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