The following data is part of a premarket notification filed by Think Surgical Inc. with the FDA for Tsolution One W/acg+ Surgical System.
| Device ID | K153647 |
| 510k Number | K153647 |
| Device Name: | TSolution One W/ACG+ 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-21 |
| Decision Date | 2016-02-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M9461082000 | K153647 | 000 |
| M9461056530 | K153647 | 000 |
| M9461049480 | K153647 | 000 |
| M9461037250 | K153647 | 000 |
| M9461035930 | K153647 | 000 |
| M9461034260 | K153647 | 000 |
| M9461034140 | K153647 | 000 |
| M9461033840 | K153647 | 000 |
| M9461032050 | K153647 | 000 |
| M9461029400 | K153647 | 000 |
| M9461027090 | K153647 | 000 |
| M9461057160 | K153647 | 000 |
| M9461057170 | K153647 | 000 |
| M9461059340 | K153647 | 000 |
| M9461076660 | K153647 | 000 |
| M9461076650 | K153647 | 000 |
| M9461076500 | K153647 | 000 |
| M9461076450 | K153647 | 000 |
| M9461076440 | K153647 | 000 |
| M9461076420 | K153647 | 000 |
| M9461063820 | K153647 | 000 |
| M946106298040 | K153647 | 000 |
| M946106298030 | K153647 | 000 |
| M9461062190 | K153647 | 000 |
| M9461005730 | K153647 | 000 |