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 |