Device Classification Name |
orthopedic stereotaxic instrument
|
510(k) Number |
K210555 |
Device Name |
7D Surgical System - Drill Guide |
Applicant |
7D Surgical Inc. |
60 scarsdale road, unit 118 |
Toronto,
CA
M3B 2R7
|
|
Applicant Contact |
Daniel Zisind |
Correspondent |
7D Surgical Inc. |
60 scarsdale road, unit 118 |
Toronto,
CA
M3B 2R7
|
|
Correspondent Contact |
Daniel Zisind |
Regulation Number | 882.4560
|
Classification Product Code |
|
Date Received | 02/25/2021 |
Decision Date | 03/23/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|