The following data is part of a premarket notification filed by Medacta International with the FDA for Mecta-c Tipeek.
| Device ID | K142744 |
| 510k Number | K142744 |
| Device Name: | Mecta-C TiPEEK |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | Medacta International Strada Regina Castel San Pietro, CH Ch 6874 |
| Contact | Adam Gross |
| Correspondent | Michael G Loiterman Medacta USA 1556 W Carroll Ave Chicago, IL 60607 |
| Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-24 |
| Decision Date | 2015-05-07 |
| Summary: | summary |