The following data is part of a premarket notification filed by Depuy Mitek, A Johnson & Johnson Company with the FDA for Intrafix Tibial Sheath.
| Device ID | K102443 |
| 510k Number | K102443 |
| Device Name: | INTRAFIX TIBIAL SHEATH |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 325 PARAMOUNT DR. Raynham, MA 02767 |
| Contact | Deep Pal |
| Correspondent | Deep Pal DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 325 PARAMOUNT DR. Raynham, MA 02767 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-08-26 |
| Decision Date | 2010-10-20 |
| Summary: | summary |