Device Classification Name |
prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer
|
510(k) Number |
K181794 |
Device Name |
Truliant Porous Femoral Components |
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 | 888.3565
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/05/2018 |
Decision Date | 09/28/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|