Device Classification Name |
prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer
|
510(k) Number |
K213781 |
Device Name |
ATTUNE® Porous Fixed Bearing Tibial Base with AFFIXIUM™ 3DP |
Applicant |
DePuy Ireland UC |
Loughbeg |
Ringaskiddy,
IE
|
|
Applicant Contact |
Erin Combs |
Correspondent |
DePuy Orthopaedics. Inc. |
700 Orthopaedic Drive |
Warsaw,
IN
46582
|
|
Correspondent Contact |
Hannah Foley |
Regulation Number | 888.3565
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/03/2021 |
Decision Date | 01/18/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|