AXSOS LOCKED PLATING 4.0MM LOCKING INSERTS


Device Classification Name

plate, fixation, bone

510(k) Number K110176
Device Name AXSOS LOCKED PLATING 4.0MM LOCKING INSERTS
Applicant
HOWMEDICA OSTEONICS CORP DBA STRYKER ORTHOPAEDICS
325 corporate drive
mahwah, 
NJ 
07430

Applicant Contact anthony dennis
Correspondent
HOWMEDICA OSTEONICS CORP DBA STRYKER ORTHOPAEDICS
325 corporate drive
mahwah, 
NJ 
07430

Correspodent Contact anthony dennis
Regulation Number 888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received 01/21/2011
Decision Date 02/15/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No