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FDA 510(k) Application Details - K031280
Device Classification Name
Instrument, Surgical, Sonic And Accessory/Attachment
More FDA Info for this Device
510(K) Number
K031280
Device Name
Instrument, Surgical, Sonic And Accessory/Attachment
Applicant
BIOMET, INC.
56 EAST BELL DR.
P.O. BOX 587
WARSAW, IN 46581-0587 US
Other 510(k) Applications for this Company
Contact
PATRICIA SANDBORN BERES
Other 510(k) Applications for this Contact
Regulation Number
888.4580
More FDA Info for this Regulation Number
Classification Product Code
JDX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/22/2003
Decision Date
09/22/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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