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FDA 510(k) Application Details - K111908
Device Classification Name
Screw, Fixation, Bone
More FDA Info for this Device
510(K) Number
K111908
Device Name
Screw, Fixation, Bone
Applicant
BIOMET MICROFIXATION, INC.
1520 TRADEPORT DR.
JACKSONVILLE, FL 32218 US
Other 510(k) Applications for this Company
Contact
KIM REED
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
07/05/2011
Decision Date
11/29/2011
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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