Device Classification Name |
orthopedic stereotaxic instrument
|
510(k) Number |
K221928 |
Device Name |
ROSA® Knee System |
Applicant |
Orthosoft d/b/a Zimmer CAS |
75 Queen Street, Suite 3300 |
Montreal,
CA
H3C 2N6
|
|
Applicant Contact |
Kavina Veeren |
Correspondent |
Orthosoft d/b/a Zimmer CAS |
75 Queen Street, Suite 3300 |
Montreal,
CA
H3C 2N6
|
|
Correspondent Contact |
Kavina Veeren |
Regulation Number | 882.4560
|
Classification Product Code |
|
Date Received | 07/01/2022 |
Decision Date | 10/04/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|