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FDA 510(k) Application Details - K160125
Device Classification Name
Intervertebral Fusion Device With Bone Graft, Cervical
More FDA Info for this Device
510(K) Number
K160125
Device Name
Intervertebral Fusion Device With Bone Graft, Cervical
Applicant
K2M
751 Miller Drive SE
Leesburg, VA 20175 US
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Contact
Nancy Giezen
Other 510(k) Applications for this Contact
Regulation Number
888.3080
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Classification Product Code
ODP
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More FDA Info for this Product Code
Date Received
01/20/2016
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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