The following data is part of a premarket notification filed by Think Surgical Inc. with the FDA for Tcat (r) Tha Instrument Tray Set.
| Device ID | K180127 |
| 510k Number | K180127 |
| Device Name: | TCAT (R) THA Instrument Tray Set |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Applicant | THINK Surgical Inc. 47201 Lakeview Blvd. Fremont, CA 94538 |
| Contact | John Hahn |
| Correspondent | George J. Prendergast THINK Surgical, Incorporated 47201 Lakeview Blvd. Fremont, CA 94538 |
| Product Code | KCT |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-17 |
| Decision Date | 2019-03-15 |