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FDA 510(k) Application Details - K031585
Device Classification Name
Orthosis, Spondyloisthesis Spinal Fixation
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510(K) Number
K031585
Device Name
Orthosis, Spondyloisthesis Spinal Fixation
Applicant
U&I CORP., AMERICA
6132 SOUTH 380 WEST,
MURRAY, UT 84107-6988 US
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Contact
PATRICK MOORE
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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
05/21/2003
Decision Date
06/27/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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