INBONE TOTAL ANKLE SYSTEM MODEL 200347902


Device Classification Name

prosthesis, ankle, semi-constrained, cemented, metal/polymer

510(k) Number K103374
Device Name INBONE TOTAL ANKLE SYSTEM MODEL 200347902
Applicant
WRIGHT MEDICAL TECHNOLOGY, INC.
5677 airline rd.
arlington, 
TN 
38002

Applicant Contact kelsey lee
Correspondent
WRIGHT MEDICAL TECHNOLOGY, INC.
5677 airline rd.
arlington, 
TN 
38002

Correspodent Contact kelsey lee
Regulation Number 888.3110
Classification Product Code
HSN  
Date Received 11/17/2010
Decision Date 12/14/2010
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No