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FDA 510(k) Application Details - K050078
Device Classification Name
Orthosis, Spondyloisthesis Spinal Fixation
More FDA Info for this Device
510(K) Number
K050078
Device Name
Orthosis, Spondyloisthesis Spinal Fixation
Applicant
ALPHATEC/NEXMED
6110 CORTE DEL CEDRO
CARLSBAD, CA 92009 US
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Contact
ELLEN A YARNALL
Other 510(k) Applications for this Contact
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
01/13/2005
Decision Date
02/18/2005
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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