The following data is part of a premarket notification filed by Think Surgical Inc. with the FDA for Tsolution One Surgical System Model 210.
| Device ID | K170430 |
| 510k Number | K170430 |
| Device Name: | TSolution One Surgical System Model 210 |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | THINK Surgical Inc. 47320 Mission Falls Court Fremont, CA 94539 |
| Contact | In K. Mun |
| Correspondent | Glen Emelock The CRO Group, Inc. 32 Harrison St. Melrose, MA 02176 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-02-13 |
| Decision Date | 2017-03-06 |
| Summary: | summary |