Device Classification Name |
Orthopedic Stereotaxic Instrument
|
510(k) Number |
K213708 |
Device Name |
ROSA® Knee System |
Applicant |
Orthosoft, Inc (d/b/a Zimmer CAS) |
75 Queen St, Suite 3300 |
Montreal,
CA
H3C 2N6
|
|
Applicant Contact |
Paul Hardy |
Correspondent |
Orthosoft, Inc (d/b/a Zimmer CAS) |
75 Queen St, Suite 3300 |
Montreal,
CA
H3C 2N6
|
|
Correspondent Contact |
Paul Hardy |
Regulation Number | 882.4560
|
Classification Product Code |
|
Date Received | 11/24/2021 |
Decision Date | 04/22/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|