Device Classification Name |
orthopedic stereotaxic instrument
|
510(k) Number |
K200888 |
Device Name |
OMNIBotics Knee System |
Applicant |
Corin Ltd. |
480 Paramount Drive |
Raynham,
MA
02767
|
|
Applicant Contact |
Christina Rovaldi |
Correspondent |
Bio Vera Inc. |
65 Promenade Saint Louis |
Notre Dame de LIle Perrot,
CA
J7v7p2
|
|
Correspondent Contact |
Robert A. Poggie |
Regulation Number | 882.4560
|
Classification Product Code |
|
Date Received | 04/03/2020 |
Decision Date | 06/27/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|