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FDA 510(k) Application Details - K113084
Device Classification Name
Screw, Fixation, Bone
More FDA Info for this Device
510(K) Number
K113084
Device Name
Screw, Fixation, Bone
Applicant
RENOVIS SURGICAL TECHNOLOGIES, LLC
200 HOMER AVE.
ASHLAND, MA 01721 US
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Contact
DAVID F ROTHKOPF
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
10/18/2011
Decision Date
12/09/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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