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FDA 510(k) Application Details - K973240
Device Classification Name
Pin, Fixation, Smooth
More FDA Info for this Device
510(K) Number
K973240
Device Name
Pin, Fixation, Smooth
Applicant
SYNTHES (USA)
1690 RUSSELL RD.
POST OFFICE BOX 1766
PAOLI, PA 19301 US
Other 510(k) Applications for this Company
Contact
SHERI L MUSGNUNG
Other 510(k) Applications for this Contact
Regulation Number
888.3040
More FDA Info for this Regulation Number
Classification Product Code
HTY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/28/1997
Decision Date
11/20/1997
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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