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FDA 510(k) Application Details - K143334
Device Classification Name
Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
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510(K) Number
K143334
Device Name
Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
Applicant
K2M, INC
571 MILLER DRIVE SE
LEESBURG, VA 20175 US
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Contact
NANCY GIEZEN
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
11/20/2014
Decision Date
01/09/2015
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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