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FDA 510(k) Application Details - K983967
Device Classification Name
Plate, Fixation, Bone
More FDA Info for this Device
510(K) Number
K983967
Device Name
Plate, Fixation, Bone
Applicant
BIOMET, INC.
P.O. BOX 587
AIRPORT INDUSTRIAL PARK
WARSAW, IN 46581-0587 US
Other 510(k) Applications for this Company
Contact
LONNIE WITHAM
Other 510(k) Applications for this Contact
Regulation Number
888.3030
More FDA Info for this Regulation Number
Classification Product Code
HRS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/06/1998
Decision Date
12/16/1998
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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