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FDA 510(k) Application Details - K132280
Device Classification Name
Orthosis, Spinal Pedicle Fixation
More FDA Info for this Device
510(K) Number
K132280
Device Name
Orthosis, Spinal Pedicle Fixation
Applicant
ALTUS PARTNERS
5129 W CHESTER PIKE
NEWTOWN SQUARE, PA 19073-0000 US
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Contact
CLAUDIA HILL
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
07/23/2013
Decision Date
10/31/2013
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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