STRYKER UNIVERSAL NEURO 3 SYSTEM


Device Classification Name

plate, cranioplasty, preformed, alterable

510(k) Number K112557
Device Name STRYKER UNIVERSAL NEURO 3 SYSTEM
Applicant
Stryker
750 trade centre way
ste 200
portage, 
MI 
49002

Applicant Contact rob yamashita
Correspondent
Stryker
750 trade centre way
ste 200
portage, 
MI 
49002

Correspodent Contact rob yamashita
Regulation Number 882.5320
Classification Product Code
GWO  
Subsequent Product Codes
GXR   HBW  
Date Received 09/02/2011
Decision Date 01/05/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No