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FDA 510(k) Application Details - K191494
Device Classification Name
Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
More FDA Info for this Device
510(K) Number
K191494
Device Name
Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
Applicant
Baui Biotech Co., Ltd.
6F., No. 8, Sec.1, Zhongxing Rd., Wugu Dist.
New Taipei City 24872 TW
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Contact
Herman Jhan
Other 510(k) Applications for this Contact
Regulation Number
888.3070
More FDA Info for this Regulation Number
Classification Product Code
NKB
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More FDA Info for this Product Code
Date Received
06/05/2019
Decision Date
08/12/2019
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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