Device Classification Name |
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
|
510(k) Number |
K220483 |
Device Name |
Platform® Acetabular System |
Applicant |
Total Joint Orthopedics, Inc. |
1567 E. Stratford Avenue |
Salt Lake City,
UT
84106
|
|
Applicant Contact |
Chris Weaber |
Correspondent |
Mcra LLC. |
803 7th Street NW |
Washington,
DC
20001
|
|
Correspondent Contact |
Holly Rhodes |
Regulation Number | 888.3353
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 02/18/2022 |
Decision Date | 09/23/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|