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FDA 510(k) Application Details - K012193
Device Classification Name
Component, Traction, Invasive
More FDA Info for this Device
510(K) Number
K012193
Device Name
Component, Traction, Invasive
Applicant
SMITH & NEPHEW, INC.
1450 BROOKS RD.
MEMPHIS, TN 38116 US
Other 510(k) Applications for this Company
Contact
JEFF F DOERZBACHER
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
07/12/2001
Decision Date
07/11/2002
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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