Device Classification Name |
prosthesis, ankle, semi-constrained, cemented, metal/polymer
|
510(k) Number |
K051023 |
Device Name |
TOPEZ TOTAL ANKLE REPLACEMENT |
Applicant |
TOPEZ ORTHOPEDICS, INC |
4655 KIRKWOOD COURT |
BOULDER,
CO
80301
|
|
Applicant Contact |
LEWIS WARD |
Correspondent |
TOPEZ ORTHOPEDICS, INC |
4655 KIRKWOOD COURT |
BOULDER,
CO
80301
|
|
Correspondent Contact |
LEWIS WARD |
Regulation Number | 888.3110
|
Classification Product Code |
|
Date Received | 04/22/2005 |
Decision Date | 11/15/2005 |
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
|
|
|