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FDA 510(k) Application Details - K151818
Device Classification Name
More FDA Info for this Device
510(K) Number
K151818
Device Name
SImmetry Sacroiliac Joint Fusion System
Applicant
Zyga Technology, Inc.
5600 Rowland Road, Suite 200
Minnetonka, MN 55343 US
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Contact
Diane Brinza
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Regulation Number
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Classification Product Code
OUR
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Date Received
07/06/2015
Decision Date
08/05/2015
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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