Device Classification Name |
prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer
|
510(k) Number |
K181635 |
Device Name |
GMK Sphere CR Tibial Inserts |
Applicant |
Medacta International SA |
Strada Regina |
Castel San Pietro,
CH
CH-6874
|
|
Applicant Contact |
Stefano Baj |
Correspondent |
Medacta USA |
3973 Delp Street |
Memphis,
TN
38118
|
|
Correspondent Contact |
Chris Lussier |
Regulation Number | 888.3560
|
Classification Product Code |
|
Date Received | 06/21/2018 |
Decision Date | 08/23/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|