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FDA 510(k) Application Details - K991326
Device Classification Name
Orthosis, Spinal Pedicle Fixation
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510(K) Number
K991326
Device Name
Orthosis, Spinal Pedicle Fixation
Applicant
SCIEN'TX USA INC.
9800 METRIC BLVD.
AUSTIN, TX 78758 US
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Contact
DEBBIE DE LOS SANTOS
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Regulation Number
888.3070
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Classification Product Code
MNI
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More FDA Info for this Product Code
Date Received
04/19/1999
Decision Date
11/08/1999
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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