Device Classification Name |
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
|
510(k) Number |
K182502 |
Device Name |
Alteon Acetabular Cup System |
Applicant |
Exactech, Inc |
2320 NW 66th CT |
Gainesville,
FL
32653
|
|
Applicant Contact |
Patrick Hughes |
Correspondent |
Exactech, Inc |
2320 NW 66th CT |
Gainesville,
FL
32653
|
|
Correspondent Contact |
Patrick Hughes |
Regulation Number | 888.3358
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 09/12/2018 |
Decision Date | 03/13/2019 |
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
|
|
|