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FDA 510(k) Application Details - K151648
Device Classification Name
Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
More FDA Info for this Device
510(K) Number
K151648
Device Name
Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
Applicant
Altus Partners, LLC
5129 West Chester Pike
Newtown Square, PA 19073 US
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Contact
Claudia Hill
Other 510(k) Applications for this Contact
Regulation Number
888.3070
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Classification Product Code
NKB
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More FDA Info for this Product Code
Date Received
06/18/2015
Decision Date
10/16/2015
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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