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FDA 510(k) Application Details - K032398
Device Classification Name
Orthosis, Spinal Pedicle Fixation
More FDA Info for this Device
510(K) Number
K032398
Device Name
Orthosis, Spinal Pedicle Fixation
Applicant
SPINEVISION, INC.
3003 SUMMIT BLVD. STE 1500
ATLANTA, GA 30319 US
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Contact
LYNETTE WHITAKER
Other 510(k) Applications for this Contact
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
08/04/2003
Decision Date
10/31/2003
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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