ORTHOLOC 3DI ANKLE FUSION PLATING SYSTEM


Device Classification Name

plate, fixation, bone

510(k) Number K121425
Device Name ORTHOLOC 3DI ANKLE FUSION PLATING SYSTEM
Applicant
WRIGHT MEDICAL TECHNOLOGY, INC.
5677 airline rd.
arlington, 
TN 
38002

Applicant Contact samir ibrahim
Correspondent
WRIGHT MEDICAL TECHNOLOGY, INC.
5677 airline rd.
arlington, 
TN 
38002

Correspodent Contact samir ibrahim
Regulation Number 888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received 05/14/2012
Decision Date 10/01/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Category: Uncategorized