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FDA 510(k) Application Details - K200793
Device Classification Name
Orthosis, Cervical Pedicle Screw Spinal Fixation
More FDA Info for this Device
510(K) Number
K200793
Device Name
Orthosis, Cervical Pedicle Screw Spinal Fixation
Applicant
L&K BIOMED Co., Ltd.
#201, 202 16-25, Dongbaekjungang-ro 16 beon-gil,
Giheung-gu, Yongin-si 17015 KR
Other 510(k) Applications for this Company
Contact
KiHyang Kim
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
NKG
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/26/2020
Decision Date
10/08/2020
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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