SIMPLEX X

Device Classification Name

bone cement

510(k) Number K032945
Device Name SIMPLEX X
Applicant
STRYKER CORP.
4100 e. milham ave.
kalamazoo, 
MI 
49001

Applicant Contact dannielle wheeler
Correspondent
STRYKER CORP.
4100 e. milham ave.
kalamazoo, 
MI 
49001

Correspodent Contact dannielle wheeler
Regulation Number 888.3027
Classification Product Code
LOD  
Subsequent Product Code
NDN  
Date Received 09/22/2003
Decision Date 05/25/2004
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls