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FDA 510(k) Application Details - K080879
Device Classification Name
Pin, Fixation, Smooth
More FDA Info for this Device
510(K) Number
K080879
Device Name
Pin, Fixation, Smooth
Applicant
BIORETEC LTD
HERMIAKATU 22 MODULIGHT BLDG
TAMPERE FI-33720 FI
Other 510(k) Applications for this Company
Contact
MARI RUOTSALAINEN
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
03/31/2008
Decision Date
06/24/2008
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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