The following data is part of a premarket notification filed by Think Surgical, Inc. with the FDA for Tsolution® One Total Knee Application.
| Device ID | K201255 |
| 510k Number | K201255 |
| Device Name: | TSolution® One Total Knee Application |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | THINK Surgical, Inc. 47201 Lakeview Blvd Fremont, CA 94538 |
| Contact | Meliha Mulalic |
| Correspondent | Meliha Mulalic THINK Surgical, Inc. 47201 Lakeview Blvd Fremont, CA 94538 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-05-11 |
| Decision Date | 2020-06-10 |