510(k) K260010 · OLO Orthopedic Stereotaxic Instrument
TMINI® Miniature Robotic System
| Applicant | THINK Surgical, Inc., Fremont CA, US |
| Decision | Substantially Equivalent, Mar 3, 2026 |
| Received | Jan 2, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260010
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 9, 2026 | Think Surgical, Inc. TMINI Femur Tracking Array REF 109003
UDI-DI code: M9461090030
TMINI Tibia Tracking Array REF 109004
UDI-DI code: M9461090040
TMINI Miniature Robotic System is indicated as a stereotaxic instrumenta Open, Classified |
OLO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.