OXFORD ANKLE FUSION NAIL(AFN) SYSTEM


Device Classification Name

rod, fixation, intramedullary and accessories

510(k) Number K121575
Device Name OXFORD ANKLE FUSION NAIL(AFN) SYSTEM
Applicant
ORTHO SOLUTIONS LIMITED
3150 east 200th street
prior lake, 
MN 
55372

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

Correspodent Contact al lippincott
Regulation Number 888.3020
Classification Product Code
HSB  
Date Received 05/30/2012
Decision Date 09/14/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No