MOBIS, MOVAL, SEMIAL, TETRISMODEL PEEK AND TITANIUM, KIMBA MODEL STANDARD AND MINI


Device Classification Name

intervertebral fusion device with bone graft, lumbar

510(k) Number K111792
Device Name MOBIS, MOVAL, SEMIAL, TETRISMODEL PEEK AND TITANIUM, KIMBA MODEL STANDARD AND MINI
Applicant
SIGNUS MEDIZINTECHNIK GMBH
8202 sherman road
chesterland, 
OH 
44026 -2141

Applicant Contact karen e warden, phd
Correspondent
SIGNUS MEDIZINTECHNIK GMBH
8202 sherman road
chesterland, 
OH 
44026 -2141

Correspodent Contact karen e warden, phd
Regulation Number 888.3080
Classification Product Code
MAX  
Subsequent Product Code
MQP  
Date Received 06/27/2011
Decision Date 03/05/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No