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FDA 510(k) Application Details - K182991
Device Classification Name
Plate, Fixation, Bone
More FDA Info for this Device
510(K) Number
K182991
Device Name
Plate, Fixation, Bone
Applicant
EPIC Extremity, LLC
120 Marguerite Drive, Suite 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
888.3030
More FDA Info for this Regulation Number
Classification Product Code
HRS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/29/2018
Decision Date
02/13/2019
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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