TOSCA II ANTERIOR CERVICAL PLATE SYSTEM


Device Classification Name

appliance, fixation, spinal intervertebral body

510(k) Number K080815
Device Name TOSCA II ANTERIOR CERVICAL PLATE SYSTEM
Applicant
SIGNUS MEDIZINTECHNIK GMBH
8202 sherman road
chseterland, 
OH 
44026

Applicant Contact karen e warden
Correspondent
SIGNUS MEDIZINTECHNIK GMBH
8202 sherman road
chseterland, 
OH 
44026

Correspodent Contact karen e warden
Regulation Number 888.3060
Classification Product Code
KWQ  
Date Received 03/24/2008
Decision Date 04/23/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No