TETRIS II


Device Classification Name

intervertebral fusion device with bone graft, lumbar

510(k) Number K122317
Device Name TETRIS II
Applicant
SIGNUS MEDIZINTECHNIK GMBH
po box 566
chesterland, 
OH 
44026 -2141

Applicant Contact karen e warden
Correspondent
SIGNUS MEDIZINTECHNIK GMBH
po box 566
chesterland, 
OH 
44026 -2141

Correspodent Contact karen e warden
Regulation Number 888.3080
Classification Product Code
MAX  
Subsequent Product Code
MQP  
Date Received 08/01/2012
Decision Date 08/29/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No