Device Classification Name |
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
More FDA Info for this Device |
510(K) Number |
K212307 |
Device Name |
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer |
Applicant |
Bodycad Laboratories, Inc.
2035, rue du Haut-Bord
Quebec City G1N 4R7 CA
Other 510(k) Applications for this Company
|
Contact |
Nadine Adia
Other 510(k) Applications for this Contact |
Regulation Number |
888.3520
More FDA Info for this Regulation Number |
Classification Product Code |
HSX
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
07/23/2021 |
Decision Date |
10/12/2021 |
Decision |
SESE - SUBST EQUIV |
Classification Advisory Committee |
OR - Orthopedic |
Review Advisory Committee |
OR - Orthopedic |
Statement / Summary / Purged Status |
Summary |
Type |
Traditional |
Reviewed By Third Party |
N |
Expedited Review |
|