The following data is part of a premarket notification filed by Ncs Lab Srl with the FDA for Ncs Fish-fit Md System Fish-fit Md Compass Md.
| Device ID | K120356 |
| 510k Number | K120356 |
| Device Name: | NCS FISH-FIT MD SYSTEM FISH-FIT MD COMPASS MD |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | NCS LAB SRL VIA POLA ESTERNA 4/12 Carpi, IT 41012 |
| Contact | Matteo Mantovani |
| Correspondent | Matteo Mantovani NCS LAB SRL VIA POLA ESTERNA 4/12 Carpi, IT 41012 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-06 |
| Decision Date | 2012-12-11 |
| Summary: | summary |