STRYKER (R) PATIENT SPECIFIC POLYMER IMPLANT


Device Classification Name

plate, cranioplasty, preformed, alterable

510(k) Number K111065
Device Name STRYKER (R) PATIENT SPECIFIC POLYMER IMPLANT
Applicant
HOWMEDICA OSTEONICS CORP. DBA STRYKER ORTHOPEADICS
325 corporate drive
mahwah, 
NJ 
07430

Applicant Contact caludia wiesemann
Correspondent
HOWMEDICA OSTEONICS CORP. DBA STRYKER ORTHOPEADICS
325 corporate drive
mahwah, 
NJ 
07430

Correspodent Contact caludia wiesemann
Regulation Number 882.5320
Classification Product Code
GWO  
Subsequent Product Code
KKY  
Date Received 04/18/2011
Decision Date 07/14/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No