Device Classification Name |
prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
|
510(k) Number |
K190890 |
Device Name |
Exactech Alteon Modular Dual Mobility (MDM) System |
Applicant |
Exactech, Inc. |
2320 NW 66th Court |
Gainesville,
FL
32653
|
|
Applicant Contact |
Liz Howell |
Correspondent |
Exactech, Inc. |
2320 NW 66th Court |
Gainesville,
FL
32653
|
|
Correspondent Contact |
Liz Howell |
Regulation Number | 888.3353
|
Classification Product Code |
|
Date Received | 04/05/2019 |
Decision Date | 10/22/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|