Device Classification Name |
Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
|
510(k) Number |
K123954 |
Device Name |
INFINITY TOTAL ANKLE 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
|
|
Correspondent Contact |
SAMIR IBRAHIM |
Regulation Number | 888.3110
|
Classification Product Code |
|
Date Received | 12/21/2012 |
Decision Date | 04/01/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|