STRYKER LEIBINGER CRANIAL FIXATION SYSTEM


Device Classification Name

plate, cranioplasty, preformed, non-alterable

510(k) Number K030378
Device Name STRYKER LEIBINGER CRANIAL FIXATION SYSTEM
Applicant
STRYKER INSTRUMENTS
4100 east milham ave.
kalamazoo, 
MI 
49087

Applicant Contact wade t rutkoskie
Correspondent
STRYKER INSTRUMENTS
4100 east milham ave.
kalamazoo, 
MI 
49087

Correspodent Contact wade t rutkoskie
Regulation Number 882.5330
Classification Product Code
GXN  
Date Received 02/05/2003
Decision Date 03/20/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No