ORTHOLOC 3DI MIDFOOT/FLATFOOT SYSTEM


Device Classification Name

plate, fixation, bone

510(k) Number K121651
Device Name ORTHOLOC 3DI MIDFOOT/FLATFOOT SYSTEM
Applicant
WRIGHT MEDICAL TECHNOLOGY, INC.
5677 airline rd.
arlington, 
TN 
38002

Applicant Contact leslie fitch
Correspondent
WRIGHT MEDICAL TECHNOLOGY, INC.
5677 airline rd.
arlington, 
TN 
38002

Correspodent Contact leslie fitch
Regulation Number 888.3030
Classification Product Code
HRS  
Date Received 06/05/2012
Decision Date 10/12/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No