K243285
- 510(k) number
- K243285
- Device name
- TMINI Miniature Robotic System
- Applicant
- THINK Surgical, Inc. CA · US
- Product code
- OLO — Orthopedic Stereotaxic Instrument
- Decision date
- 2024-11-15
- Date received
- 2024-10-18
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Neurology
510(k) Summary (official FDA PDF): K243285.pdf
Official FDA record: K243285
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.