Device Classification Name |
prosthesis, knee, patello/femoral, semi-constrained, cemented, metal/polymer
|
510(k) Number |
K231253 |
Device Name |
Overture Orthopaedics Patellofemoral System |
Applicant |
Overture Resurfacing Inc. |
1617 3rd Ave, #287284 |
New York,
NY
10128
|
|
Applicant Contact |
Riley Williams |
Correspondent |
Cor Medical Ventures, Inc. |
2010 Jimmy Durante Blvd |
Suite 200 |
Del Mar,
CA
92014
|
|
Correspondent Contact |
Benjamin Arnold |
Regulation Number | 888.3540
|
Classification Product Code |
|
Date Received | 05/01/2023 |
Decision Date | 07/07/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|