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FDA 510(k) Application Details - K060683
Device Classification Name
Appliance, Fixation, Spinal Interlaminal
More FDA Info for this Device
510(K) Number
K060683
Device Name
Appliance, Fixation, Spinal Interlaminal
Applicant
ENDIUS, INC.
23 WEST BACON ST.
PLAINVILLE, MA 02762 US
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Contact
CHRISTINE KUNTZ-NASSIF
Other 510(k) Applications for this Contact
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
03/15/2006
Decision Date
04/18/2006
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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