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FDA 510(k) Application Details - K142264
Device Classification Name
Intervertebral Fusion Device With Bone Graft, Cervical
More FDA Info for this Device
510(K) Number
K142264
Device Name
Intervertebral Fusion Device With Bone Graft, Cervical
Applicant
Amedica Corp.
1885 West 2100 South
Salt Lake City, UT 84119 US
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Contact
William D Jordan
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
08/15/2014
Decision Date
12/08/2014
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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