The following data is part of a premarket notification filed by Curexo Technology Corporation with the FDA for Ctc Tcat(r)-tplan(r) Surgical System.
| Device ID | K140585 |
| 510k Number | K140585 |
| Device Name: | CTC TCAT(R)-TPLAN(R) SURGICAL SYSTEM |
| Classification | Orthopedic Computer Controlled Surgical System |
| Applicant | CUREXO TECHNOLOGY CORPORATION 32 HARRISON ST. Melrose, MA 02176 |
| Contact | Glen Emelock |
| Correspondent | Glen Emelock CUREXO TECHNOLOGY CORPORATION 32 HARRISON ST. Melrose, MA 02176 |
| Product Code | OJP |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-03-07 |
| Decision Date | 2014-08-18 |
| Summary: | summary |