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FDA 510(k) Application Details - K163038
Device Classification Name
Screw, Fixation, Bone
More FDA Info for this Device
510(K) Number
K163038
Device Name
Screw, Fixation, Bone
Applicant
EPIC EXTREMITY, LLC
120 MARGUERITE DR, STE 301
CRANBERRY TWP, PA 16066 US
Other 510(k) Applications for this Company
Contact
DAN SCHWARTZBAUER
Other 510(k) Applications for this Contact
Regulation Number
888.3040
More FDA Info for this Regulation Number
Classification Product Code
HWC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/31/2016
Decision Date
02/28/2017
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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