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FDA 510(k) Application Details - K130859
Device Classification Name
Screw, Fixation, Bone
More FDA Info for this Device
510(K) Number
K130859
Device Name
Screw, Fixation, Bone
Applicant
ARTHROSURFACE, INC.
28 FORGE PARKWAY
FRANKLIN, MA 02038 US
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Contact
DAWN J WILSON
Other 510(k) Applications for this Contact
Regulation Number
888.3040
More FDA Info for this Regulation Number
Classification Product Code
HWC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/28/2013
Decision Date
07/25/2013
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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