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FDA 510(k) Application Details - K172104
Device Classification Name
Appliance, Fixation, Spinal Intervertebral Body
More FDA Info for this Device
510(K) Number
K172104
Device Name
Appliance, Fixation, Spinal Intervertebral Body
Applicant
K2M Inc.
600 Hope Pkwy. SE
Leesburg, VA 20175 US
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Contact
Nancy Giezen
Other 510(k) Applications for this Contact
Regulation Number
888.3060
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Classification Product Code
KWQ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/12/2017
Decision Date
08/23/2017
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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