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 | K193135 |
| 510k Number | K193135 |
| 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 | 2019-11-12 |
| Decision Date | 2019-12-11 |