ELLIPSE LUMBAR POSTERIOR OSTEOSYNTHESIS SYSTEM


Device Classification Name

orthosis, spondylolisthesis spinal fixation

510(k) Number K081165
Device Name ELLIPSE LUMBAR POSTERIOR OSTEOSYNTHESIS SYSTEM
Applicant
SPINEART
cointrin 20 route de pre-bois
cp1813
geneva, 

CH

1215

Applicant Contact franck pennesi
Correspondent
SPINEART
cointrin 20 route de pre-bois
cp1813
geneva, 

CH

1215

Correspodent Contact franck pennesi
Regulation Number 888.3070
Classification Product Code
MNH  
Subsequent Product Codes
KWP   MNI  
Date Received 04/24/2008
Decision Date 12/17/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No