Device Classification Name |
prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer
|
510(k) Number |
K211671 |
Device Name |
Journey II Mid-Level Tibial Inserts |
Applicant |
Smith & Nephew, Inc. |
1450 East Brooks Rd |
Memphis,
TN
38116
|
|
Applicant Contact |
Kayla Franklin |
Correspondent |
Smith & Nephew, Inc. |
1450 East Brooks Rd |
Memphis,
TN
38116
|
|
Correspondent Contact |
Kayla Franklin |
Regulation Number | 888.3560
|
Classification Product Code |
|
Date Received | 06/01/2021 |
Decision Date | 08/17/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|