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FDA 510(k) Application Details - K151173
Device Classification Name
Screw, Fixation, Bone
More FDA Info for this Device
510(K) Number
K151173
Device Name
Screw, Fixation, Bone
Applicant
Biomet Microfixation
1520 Tradeport Drive
Jacksonville, FL 32218 US
Other 510(k) Applications for this Company
Contact
Lauren Jasper
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
05/01/2015
Decision Date
05/26/2015
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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