ORTHO SOLUTIONS EXTREMITY FIXATION IMPLANTS FOR OSTEOSYSNTHESIS


Device Classification Name

plate, fixation, bone

510(k) Number K111678
Device Name ORTHO SOLUTIONS EXTREMITY FIXATION IMPLANTS FOR OSTEOSYSNTHESIS
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 888.3030
Classification Product Code
HRS  
Subsequent Product Codes
HWC   JDR  
Date Received 06/15/2011
Decision Date 02/07/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No