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FDA 510(k) Application Details - K200846
Device Classification Name
Appliance, Fixation, Spinal Intervertebral Body
More FDA Info for this Device
510(K) Number
K200846
Device Name
Appliance, Fixation, Spinal Intervertebral Body
Applicant
Huvexel Co., Ltd
101-105 Megacenter, SKn Technopark, 124, Sagimakgol-ro
Jungwon-gu
Seongnam-si 13207 KR
Other 510(k) Applications for this Company
Contact
Sung Kyu Hur
Other 510(k) Applications for this Contact
Regulation Number
888.3060
More FDA Info for this Regulation Number
Classification Product Code
KWQ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/31/2020
Decision Date
05/05/2020
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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