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FDA 510(k) Application Details - K973944
Device Classification Name
Rod, Fixation, Intramedullary And Accessories
More FDA Info for this Device
510(K) Number
K973944
Device Name
Rod, Fixation, Intramedullary And Accessories
Applicant
ORTHOFIX SRL
12300 TWINBROOK PARKWAY,
SUITE 625
ROCKVILLE, MD 20852 US
Other 510(k) Applications for this Company
Contact
ROBERT L SHERIDAN
Other 510(k) Applications for this Contact
Regulation Number
888.3020
More FDA Info for this Regulation Number
Classification Product Code
HSB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/16/1997
Decision Date
12/19/1997
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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