FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TMINI Miniature Robotic System
K Number: K250877
·
Decision Jun 20, 2025
Classifications
1
FEI Numbers
370
Registration Numbers
370
Same Product Code
404
Applicant Total
9
Review Days
88
Basic Information
- Device Name
- TMINI Miniature Robotic System
- K Number
- K250877
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4560
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- THINK Surgical, Inc.
- Date Received
- March 24, 2025
- Decision Date
- June 20, 2025
- Product Code
- OLO
- Advisory Committee
- Neurology
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OLO | Orthopedic Stereotaxic Instrument | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OLO), ordered by most recent decision date.
SPINEART Navigation Instrument System
FDA 510(k)
FDA Class 2
·Neurology
Stealth Spine Clamps; ModuLeX Shank Mounts
FDA 510(k)
FDA Class 2
·Neurology
Paradigm System
FDA 510(k)
FDA Class 2
·Neurology
Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II
FDA 510(k)
FDA Class 2
·Neurology
OTS Hip
FDA 510(k)
FDA Class 2
·Neurology
Altus Spine Navigation System
FDA 510(k)
FDA Class 2
·Neurology
Other Clearances by THINK Surgical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K243481 | TMINI Miniature Robotic System | Jan 6, 2025 | Substantially Equivalent |
| K230202 | TMINI Miniature Robotic System | Apr 25, 2023 | Substantially Equivalent |
| K203468 | TCAT TKA Instrument Tray | Dec 20, 2021 | Substantially Equivalent |
| K210668 | TSolution One Total Knee Application | Apr 1, 2021 | Substantially Equivalent |
| K203040 | TSolution One Total Knee Application | Nov 13, 2020 | Substantially Equivalent |
| K201255 | TSolution® One Total Knee Application | Jun 10, 2020 | Substantially Equivalent |
| K200632 | TCAT TKA Instrument Tray Set | Apr 8, 2020 | Substantially Equivalent |
| K191369 | TSolution One Total Knee Application | Oct 8, 2019 | Substantially Equivalent |