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FDA 510(k) Application Details - K990657
Device Classification Name
Orthosis, Spondyloisthesis Spinal Fixation
More FDA Info for this Device
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
More FDA Info for this Regulation Number
Classification Product Code
MNH
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More FDA Info for this Product Code
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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