Device Classification Name |
orthopedic stereotaxic instrument
|
510(k) Number |
K230202 |
Device Name |
TMINI™ Miniature Robotic System |
Applicant |
THINK Surgical, Inc. |
47201 Lakeview Blvd |
Fremont,
CA
94538
|
|
Applicant Contact |
Meliha Mulalic |
Correspondent |
THINK Surgical, Inc. |
47201 Lakeview Blvd |
Fremont,
CA
94538
|
|
Correspondent Contact |
Meliha Mulalic |
Regulation Number | 882.4560
|
Classification Product Code |
|
Date Received | 01/25/2023 |
Decision Date | 04/25/2023 |
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
|
|
|