SiNtx Technologies Inc (SINT)

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Device Classification Name intervertebral fusion device with bone graft, lumbar
510(k) Number K161405
Device Name Valeo II Interbody Fusion Device System
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
Correspodent Contact william d. jordan
Regulation Number 888.3080
Classification Product Code
MAX
Subsequent Product Code
ODP
Date Received 05/20/2016
Decision Date 08/19/2016
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Special
Reviewed by Third Party No
Combination Product No