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FDA 510(k) Application Details - K993808
Device Classification Name
Orthosis, Spondyloisthesis Spinal Fixation
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510(K) Number
K993808
Device Name
Orthosis, Spondyloisthesis Spinal Fixation
Applicant
INTERPORE CROSS INTL.
181 TECHNOLOGY DR.
IRVINE, CA 92618-2402 US
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Contact
PROSIE REY-FESSLER
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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
11/10/1999
Decision Date
12/06/1999
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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