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FDA 510(k) Application Details - K121589
Device Classification Name
Plate, Bone
More FDA Info for this Device
510(K) Number
K121589
Device Name
Plate, Bone
Applicant
BIOMET MICROFIXATION
1520 TRADEPORT DR.
JACKSONVILLE, FL 32218 US
Other 510(k) Applications for this Company
Contact
LAUREN JASPER
Other 510(k) Applications for this Contact
Regulation Number
872.4760
More FDA Info for this Regulation Number
Classification Product Code
JEY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/31/2012
Decision Date
09/21/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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