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FDA 510(k) Application Details - K160216
Device Classification Name
Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
More FDA Info for this Device
510(K) Number
K160216
Device Name
Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
Applicant
INTELLIGENT IMPLANT SYSTEMS, LLC
3300 INTERNATIONAL AIRPORT DRIVE; STE 1100
CHARLOTTE, NC 28208 US
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Contact
MICHAEL NUTT
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Regulation Number
888.3070
More FDA Info for this Regulation Number
Classification Product Code
NKB
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More FDA Info for this Product Code
Date Received
01/29/2016
Decision Date
04/22/2016
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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