The following data is part of a premarket notification filed by Think Surgical Inc. with the FDA for Tsolution One Cup1 Surgical System.
| Device ID | K162195 |
| 510k Number | K162195 |
| Device Name: | TSolution One Cup1 Surgical System |
| 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 | 2016-08-05 |
| Decision Date | 2016-09-14 |
| Summary: | summary |