Device Classification Name |
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
|
510(k) Number |
K150066 |
Device Name |
Exactech Alteon Monobloc Revision Stem |
Applicant |
EXACTECH, INC. |
2320 N.W. 66TH CT. |
GAINESVILLE,
FL
32653
|
|
Applicant Contact |
Patrick Hughes |
Correspondent |
EXACTECH, INC. |
2320 N.W. 66TH CT. |
GAINESVILLE,
FL
32653
|
|
Correspondent Contact |
Patrick Hughes |
Regulation Number | 888.3353
|
Classification Product Code |
|
Date Received | 01/13/2015 |
Decision Date | 07/20/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|