The following data is part of a premarket notification filed by Mitek Products with the FDA for Mitek 2gii Meniscal Repair System.
| Device ID | K002406 |
| 510k Number | K002406 |
| Device Name: | MITEK 2GII MENISCAL REPAIR SYSTEM |
| Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
| Applicant | MITEK PRODUCTS 249 VANDERBILT AVE. Norwood, MA 02062 |
| Contact | Carol Chaoui |
| Correspondent | Carol Chaoui MITEK PRODUCTS 249 VANDERBILT AVE. Norwood, MA 02062 |
| Product Code | MAI |
| Subsequent Product Code | GAM |
| Subsequent Product Code | GAS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-07 |
| Decision Date | 2001-02-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10886705010264 | K002406 | 000 |
| 10886705010257 | K002406 | 000 |
| 10886705010240 | K002406 | 000 |
| 10886705010233 | K002406 | 000 |
| 10886705010226 | K002406 | 000 |