PEEK CUSTOMIZED CRAIAL IMPLANT KIT


Device Classification Name

plate, cranioplasty, preformed, alterable

510(k) Number K121153
Device Name PEEK CUSTOMIZED CRAIAL IMPLANT KIT
Applicant
Stryker
750 trade centre way
ste 200
portage, 
MI 
49002

Applicant Contact manish patel
Correspondent
Stryker
750 trade centre way
ste 200
portage, 
MI 
49002

Correspodent Contact manish patel
Regulation Number 882.5320
Classification Product Code
GWO  
Date Received 04/16/2012
Decision Date 09/14/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No