COSMIC SYSTEM


Device Classification Name

orthosis, spinal pedicle fixation

510(k) Number K080841
Device Name COSMIC SYSTEM
Applicant
ULRICH GMBH & CO. KG
754 spirit 40 park drive
st. louis, 
MO 
63005

Applicant Contact merle symes
Correspondent
ULRICH GMBH & CO. KG
754 spirit 40 park drive
st. louis, 
MO 
63005

Correspodent Contact merle symes
Regulation Number 888.3070
Classification Product Code
MNI  
Subsequent Product Code
MNH  
Date Received 03/26/2008
Decision Date 07/23/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No