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FDA 510(k) Application Details - K091202
Device Classification Name
Screw, Fixation, Bone
More FDA Info for this Device
510(K) Number
K091202
Device Name
Screw, Fixation, Bone
Applicant
MEDSHAPE SOLUTIONS
1575 NORTHSIDE DR.
SUITE 440
ATLANTA, GA 30318 US
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Contact
JACK GRIFFIS
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
04/24/2009
Decision Date
09/16/2009
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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