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FDA 510(k) Application Details - K161766
Device Classification Name
Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
More FDA Info for this Device
510(K) Number
K161766
Device Name
Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
Applicant
L&K BIOMED Co., Ltd.
#201, 202 16-25, Dongbaekjungang-ro 16 beon-gil
Giheung-gu, Yongin-si 446-916 KR
Other 510(k) Applications for this Company
Contact
Yerim An
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
06/27/2016
Decision Date
08/22/2016
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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