FDA 510(k) Application Details - K990657

Device Classification Name Orthosis, Spondyloisthesis Spinal Fixation

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510(K) Number K990657
Device Name Orthosis, Spondyloisthesis Spinal Fixation
Applicant CORIN U.S.A.
10500 UNIVERSITY CENTER DR.,
SUITE 190
TAMPA, FL 33612 US
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Contact CRAIG CORRANCE
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Regulation Number 888.3070

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Classification Product Code MNH
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Date Received 03/01/1999
Decision Date 03/26/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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