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FDA 510(k) Application Details - K011437
Device Classification Name
Orthosis, Spinal Pedicle Fixation
More FDA Info for this Device
510(K) Number
K011437
Device Name
Orthosis, Spinal Pedicle Fixation
Applicant
INTERPORE CROSS INTL.
181 TECHNOLOGY DR.
IRVINE, CA 92618-2402 US
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Contact
LYNN RODARTI
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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
05/10/2001
Decision Date
06/06/2001
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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