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FDA 510(k) Application Details - K040442
Device Classification Name
Orthosis, Spondyloisthesis Spinal Fixation
More FDA Info for this Device
510(K) Number
K040442
Device Name
Orthosis, Spondyloisthesis Spinal Fixation
Applicant
GLOBUS MEDICAL, INC.
303 SCHELL LANE
PHOENIXVILLE, PA 19460 US
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Contact
KELLY J BAKER
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Regulation Number
888.3070
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Classification Product Code
MNH
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More FDA Info for this Product Code
Date Received
02/20/2004
Decision Date
05/20/2004
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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