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FDA 510(k) Application Details - K140908
Device Classification Name
Screw, Fixation, Intraosseous
More FDA Info for this Device
510(K) Number
K140908
Device Name
Screw, Fixation, Intraosseous
Applicant
BIOMET SPORTS MEDICINE
56 EAST BELL DRIVE
WARSAW, IN 46582 US
Other 510(k) Applications for this Company
Contact
Jared Cooper
Other 510(k) Applications for this Contact
Regulation Number
872.4880
More FDA Info for this Regulation Number
Classification Product Code
DZL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/09/2014
Decision Date
10/02/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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