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FDA 510(k) Application Details - K101374
Device Classification Name
Orthosis, Spondyloisthesis Spinal Fixation
More FDA Info for this Device
510(K) Number
K101374
Device Name
Orthosis, Spondyloisthesis Spinal Fixation
Applicant
AAXTER CO., LTD
NO. 8-3, SEC. , JHONGSING RD.,
WUGU TOWNSHIP
TAIPEI 24872 TW
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Contact
JACK CHEN
Other 510(k) Applications for this Contact
Regulation Number
888.3070
More FDA Info for this Regulation Number
Classification Product Code
MNH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/17/2010
Decision Date
03/16/2011
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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