AXSOS (TM) LOCKING PLATE SYSTEM


Device Classification Name

plate, fixation, bone

510(k) Number K110476
Device Name AXSOS (TM) LOCKING PLATE SYSTEM
Applicant
STRYKER CORP.
325 corporate drive
mahwah, 
NJ 
07430

Applicant Contact estela celi
Correspondent
STRYKER CORP.
325 corporate drive
mahwah, 
NJ 
07430

Correspodent Contact estela celi
Regulation Number 888.3030
Classification Product Code
HRS  
Date Received 02/18/2011
Decision Date 03/18/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No