STERILE STORM (R) OPERATING KIT


Device Classification Name

screw, fixation, bone

510(k) Number K111001
Device Name STERILE STORM (R) OPERATING KIT
Applicant
INTELLIGENT ORTHOPAEDICS LTD
staffordshire university
business village, leek road
stoke on trent, staffordshire, 

GB

st4 2ar

Applicant Contact peter j ogrodnik
Correspondent
INTELLIGENT ORTHOPAEDICS LTD
staffordshire university
business village, leek road
stoke on trent, staffordshire, 

GB

st4 2ar

Correspodent Contact peter j ogrodnik
Regulation Number 888.3040
Classification Product Code
HWC  
Subsequent Product Code
HTY  
Date Received 04/11/2011
Decision Date 05/17/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No