INVIZIA ANTERIOR CERVICAL PLATE SYSTEM


Device Classification Name

appliance, fixation, spinal intervertebral body

510(k) Number K111796
Device Name INVIZIA ANTERIOR CERVICAL PLATE SYSTEM
Applicant
ZIMMER SPINE, INC.
7375 bush lake rd.
minneapolis, 
MN 
55439

Applicant Contact elsa linke
Correspondent
ZIMMER SPINE, INC.
7375 bush lake rd.
minneapolis, 
MN 
55439

Correspodent Contact elsa linke
Regulation Number 888.3060
Classification Product Code
KWQ  
Date Received 06/27/2011
Decision Date 10/27/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No