INSTINCT JAVA SYSTEM


Device Classification Name

orthosis, spinal pedicle fixation, for degenerative disc disease

510(k) Number K111301
Device Name INSTINCT JAVA SYSTEM
Applicant
ZIMMER SPINE
7375 bush lake road
edina, 
MN 
55439

Applicant Contact elsa a linke
Correspondent
ZIMMER SPINE
7375 bush lake road
edina, 
MN 
55439

Correspodent Contact elsa a linke
Regulation Number 888.3070
Classification Product Code
NKB  
Subsequent Product Codes
MNH   MNI  
Date Received 05/09/2011
Decision Date 08/26/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No