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FDA 510(k) Application Details - K173424
Device Classification Name
Filler, Bone Void, Calcium Compound
More FDA Info for this Device
510(K) Number
K173424
Device Name
Filler, Bone Void, Calcium Compound
Applicant
Synergy Biomedical
100 Springhouse Dr.
Suite 108
Collegeville, PA 19426 US
Other 510(k) Applications for this Company
Contact
Mark Borden
Other 510(k) Applications for this Contact
Regulation Number
888.3045
More FDA Info for this Regulation Number
Classification Product Code
MQV
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/01/2017
Decision Date
09/12/2018
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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