Device Classification Name |
prosthesis, knee, patello/femoral, semi-constrained, cemented, metal/polymer
|
510(k) Number |
K221048 |
Device Name |
Episealer Patellofemoral System |
Applicant |
Episurf Medical, Inc. |
220 E 42nd Street, Suite 409A |
New York,
NY
10017
|
|
Applicant Contact |
Katarina Flodstrom |
Correspondent |
MCRA, LLC |
803 7th St NW |
Washington,
DC
20001
|
|
Correspondent Contact |
Hollace Saas Rhodes |
Regulation Number | 888.3540
|
Classification Product Code |
|
Date Received | 04/08/2022 |
Decision Date | 12/23/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|