The following data is part of a premarket notification filed by Depuy Mitek, A Johnson & Johnson Company with the FDA for Omnispan Meniscal Repair System/0 Degree, Model 228140, Rapidloc A2 Meniscal Repair System/12 Degree, Model 228141.
| Device ID | K092836 |
| 510k Number | K092836 |
| Device Name: | OMNISPAN MENISCAL REPAIR SYSTEM/0 DEGREE, MODEL 228140, RAPIDLOC A2 MENISCAL REPAIR SYSTEM/12 DEGREE, MODEL 228141 |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 325 PARAMOUNT DR. Raynham, MA 02767 |
| Contact | Zheng Liu |
| Correspondent | Zheng Liu DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 325 PARAMOUNT DR. Raynham, MA 02767 |
| Product Code | MBI |
| Subsequent Product Code | GAT |
| Subsequent Product Code | NEW |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-15 |
| Decision Date | 2010-02-04 |
| Summary: | summary |