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FDA 510(k) Application Details - K163363
Device Classification Name
Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
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510(K) Number
K163363
Device Name
Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
Applicant
SurgTech Inc.
24600 Center Ridge Road, Suite 195
Westlake, OH 44145 US
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Contact
Xuegong Yu
Other 510(k) Applications for this Contact
Regulation Number
888.3070
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Classification Product Code
NKB
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More FDA Info for this Product Code
Date Received
11/30/2016
Decision Date
04/05/2017
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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