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FDA 510(k) Application Details - K133103
Device Classification Name
Orthosis, Spinal Pedicle Fixation
More FDA Info for this Device
510(K) Number
K133103
Device Name
Orthosis, Spinal Pedicle Fixation
Applicant
K7 LLC
PO BOX 566
CHESTERLAND, OH 44026-2141 US
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Contact
KAREN E WARDEN
Other 510(k) Applications for this Contact
Regulation Number
888.3070
More FDA Info for this Regulation Number
Classification Product Code
MNI
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More FDA Info for this Product Code
Date Received
09/30/2013
Decision Date
01/27/2014
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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