PHANTOM PLUS CERAMIC CAGE SYSTEM


Device Classification Name

intervertebral fusion device with bone graft, lumbar

510(k) Number K121892
Device Name PHANTOM PLUS CERAMIC CAGE SYSTEM
Applicant
AMEDICA CORP.
615 arapeen drive
salt lake city, 
UT 
84108

Applicant Contact robert m wolfarth
Correspondent
AMEDICA CORP.
615 arapeen drive
salt lake city, 
UT 
84108

Correspodent Contact robert m wolfarth
Regulation Number 888.3080
Classification Product Code
MAX  
Subsequent Product Code
ODP  
Date Received 06/29/2012
Decision Date 08/24/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No