The following data is part of a premarket notification filed by Depuy Mitek, A Johnson And Johnson Company with the FDA for Rigidloop Adjustable Cortical Implant: Standard, Long And Xl.
| Device ID | K140324 |
| 510k Number | K140324 |
| Device Name: | RIGIDLOOP ADJUSTABLE CORTICAL IMPLANT: STANDARD, LONG AND XL |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | DEPUY MITEK, A JOHNSON AND JOHNSON COMPANY 325 Paramount Drive Raynham, MA 02767 |
| Contact | Yayoi Fujimaki |
| Correspondent | Yayoi Fujimaki DEPUY MITEK, A JOHNSON AND JOHNSON COMPANY 325 Paramount Drive Raynham, MA 02767 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-10 |
| Decision Date | 2014-07-07 |
| Summary: | summary |