Device Classification Name |
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
More FDA Info for this Device |
510(K) Number |
K222436 |
Device Name |
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented |
Applicant |
Meril Healthcare Pvt. Ltd.
Survey No. 135/2/B & 174/2, H1-H3 , Meril Park,
Muktanand Marg, Chala
Vapi 396191 IN
Other 510(k) Applications for this Company
|
Contact |
Yamini Patel
Other 510(k) Applications for this Contact |
Regulation Number |
888.3358
More FDA Info for this Regulation Number |
Classification Product Code |
LPH
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
08/12/2022 |
Decision Date |
05/09/2023 |
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 |
|