ORTHO SOLUTIONS TRAUMA IMPLANTS FOR OSTEOSYNTHESIS


Device Classification Name

screw, fixation, bone

510(k) Number K110895
Device Name ORTHO SOLUTIONS TRAUMA IMPLANTS FOR OSTEOSYNTHESIS
Applicant
ORTHO SOLUTIONS LIMITED
3150 e. 200th street
prior lake, 
MN 
55372

Applicant Contact al lippincott
Correspondent
ORTHO SOLUTIONS LIMITED
3150 e. 200th street
prior lake, 
MN 
55372

Correspodent Contact al lippincott
Regulation Number 888.3040
Classification Product Code
HWC  
Subsequent Product Codes
HTN   HTY   JDQ   JDW  
Date Received 03/30/2011
Decision Date 12/19/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No