Device Classification Name |
orthopedic stereotaxic instrument
|
510(k) Number |
K191507 |
Device Name |
Intellijoint® Navigation System |
Applicant |
Intellijoint Surgical Inc. |
60 Bathurst Drive |
Unit 6 |
Waterloo,
CA
N2V 2A9
|
|
Applicant Contact |
Breanne Cuddington |
Correspondent |
Intellijoint Surgical Inc. |
809 Wellington St. N, Unit 2 |
Kitchener,
CA
N2H 5L6
|
|
Correspondent Contact |
Breanne Cuddington |
Regulation Number | 882.4560
|
Classification Product Code |
|
Date Received | 06/06/2019 |
Decision Date | 10/01/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|