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FDA 510(k) Application Details - K052404
Device Classification Name
Appliance, Fixation, Spinal Interlaminal
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510(K) Number
K052404
Device Name
Appliance, Fixation, Spinal Interlaminal
Applicant
K2M, LLC
751 MILLER DRIVE SE, SUITE F1
LEESBURG, VA 20175 US
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Contact
RICHARD W WOODS
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Regulation Number
888.3050
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Classification Product Code
KWP
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More FDA Info for this Product Code
Date Received
09/01/2005
Decision Date
05/23/2006
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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