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FDA 510(k) Application Details - K021579
Device Classification Name
Screw, Fixation, Bone
More FDA Info for this Device
510(K) Number
K021579
Device Name
Screw, Fixation, Bone
Applicant
MAGLY ORTHOPEDICS, LLC
15009 NE 195TH ST.
WOODINVILLE, WA 98072 US
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Contact
DAVE STINSON
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
05/14/2002
Decision Date
08/09/2002
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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