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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name intervertebral fusion device with bone graft, lumbar
510(k) Number K142347
Device Name Amedica Valeo II Interbody Fusion Device
Applicant
Amedica Corp
1885 West 2100 South
Salt Lake City,  UT  84119
Applicant Contact William D Jordan
Correspondent
Amedica Corp
1885 West 2100 South
Salt Lake City,  UT  84119
Correspondent Contact William D Jordan
Regulation Number888.3080
Classification Product Code
MAX  
Subsequent Product Code
ODP  
Date Received08/22/2014
Decision Date 11/18/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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