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FDA 510(k) Application Details - K031941
Device Classification Name
Component, Traction, Invasive
More FDA Info for this Device
510(K) Number
K031941
Device Name
Component, Traction, Invasive
Applicant
HOWMEDICA OSTEONICS CORP.
59 ROUTE 17 SOUTH
ALLENDALE, NJ 07401-1677 US
Other 510(k) Applications for this Company
Contact
VIVIAN KELLY
Other 510(k) Applications for this Contact
Regulation Number
888.3040
More FDA Info for this Regulation Number
Classification Product Code
JEC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/24/2003
Decision Date
07/24/2003
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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